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Epimed International, Inc.

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 119-2080Model Nerve Block NeedleRef 131-2245Ref 201-2430Model Spring Guide Epidural CatheterRef 116-2235Ref 241-1610Model RF CannulaRef 125-2235TModel Epidural Introducer NeedleRef 116-2035Ref 126-2035Ref 135-1857Model Flexible Epidural Introducer (FIC)/Blunt Cannula Access (BAC)Ref 159-2124Ref 287-1610Ref 286-2005Ref 117-2080Ref 115-2280Ref 135-1420Ref 117-2260Ref 286-2205Ref 169-2412Ref 126-1860Ref 123-2020Ref 156-2112Ref 125-1860TRef 100-1415Ref 131-2260Ref 266-2210Ref 123-2028Ref 134-1455Ref 107-1616Ref 118-2045Ref 231-1610Ref 121-2235Ref 1911-221Model Nearaxial Catheter ConnectorRef 105-1516Ref 116-2245Ref 115-2235Ref 109-1613Ref 116-2060Ref 135-1735Ref 131-2060Ref 282-1615Ref 155-2343Ref 107-1416Ref 106-1616Ref 288-2010Ref 118-2060Ref 116-2535Ref 166-2024Ref 156-2124Ref 165-1936Ref 117-2535Ref 1911-219Ref 267-2015Ref 165-2036Ref 261-2010Ref 106-1313Ref 122-2060Ref 125-2045TRef 130-2535Ref 287-1815Ref 116-2270Ref 134-1435Ref 161-2124Ref 284-2010Ref 153-2340Ref 164-1936Ref 135-1837Ref 106-1712Ref 193-2036Ref 126-2235Ref 287-1810Ref 105-1515Ref 158-2114Ref 266-2215Ref 155-2540Ref 156-2118Ref 125-1835TRef 107-1314Ref 126-1735Ref 266-2010Ref 100-1417Ref 105-1416Ref 287-2015Ref 231-2010Ref 105-1712Ref 106-1613Ref 117-2045Ref 281-2005Ref 135-1825Ref 126-2225Ref 243-1610Ref 257-1810Ref 287-2010Ref 233-2010

by Epimed International, Inc.

Identity

Trade Name
Epimed International,Inc. EUDAMED
Epimed FDA UDI
Epimed International, Inc. FDA UDI
Generic Name
Peripheral nerve-block sharp needle FDA UDI
Epidural needle, non-threaded FDA UDI
Epidural anaesthesia set, non-medicated FDA UDI
Peripheral nerve-block blunt needle access cannula FDA UDI
Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Non-vascular catheter introduction set FDA UDI
Peripheral nerve-block blunt needle FDA UDI
Luer/Luer linear connector, single-use FDA UDI
Device Name
22g TW x 3.5" Chiba Style Needle FDA UDI
22g RW X 2.5" Tuohy Needle for Injection FDA UDI
Spirol® 19g Closed End Styletted 36" FDA UDI
25g RW x 3.5" Coudé® Blunt Nerve Block Needle w/ Introducer FDA UDI
25g RW x 3.5" Blunt Nerve Block Needle w/ Introducer FDA UDI
R-F™ B Bevel 16g RW 10cm w/ 10mm Straight Active Tip FDA UDI
Percutaneous Introducer w/ 14g RW x 2.7" B Bevel FDA UDI
R-F™ Cannula Coudé® Blunt 20g x 15cm w/ 10mm Active Tip FDA UDI
22g RW x 3.5" Blunt Nerve Block Needle FDA UDI
RX Epidural Needle 16g TW x 6.0" FDA UDI
20g TW x 4.5" Coudé® Blunt Nerve Block Needle FDA UDI
20g TW x 8.0" Coudé® Blunt Nerve Block Needle w/ Introducer FDA UDI
R.K.™ 15g TW x 3.5" FDA UDI
R-F™ Cannula Blunt 20g TW x 10cm w/ 5mm Active Tip FDA UDI
Versa-Kath® 21g x 18" FDA UDI
17g TW X 3.5" Tuohy Needle for Injection FDA UDI
R-F™ Cobra Injector Cannula Coudé® 18g x 10cm w/ 10mm Active Tip FDA UDI
RX-2™ Coudé® Epidural Needle 13g TW x 6.0" FDA UDI
Blunt Access Cannula 18g XTW x 1.8" Sharp FDA UDI
Neo-Kath™ 24g x 30" Caudal Set FDA UDI
Brevi-STF® 19g x 14" FDA UDI
18g TW X 6.0" Tuohy Needle for Injection FDA UDI
RX Epidural Needle 13g TW x 6.0" FDA UDI
Spirol® Close End 20g x 36" Short Crawford Set, Styletted FDA UDI
R-F™ Cannula Coudé® B-Bevel 20g x 15cm w/ 10mm Active Tip FDA UDI
RX Coudé® Epidural Needle 16g TW x 3.5" FDA UDI
R-F™ B Bevel 20g RW 10cm w/ 10mm Straight Active Tip FDA UDI
R-F™ Cannula Coudé® B-Bevel 22g x 5cm w/ 5mm Active Tip FDA UDI
RX Epidural Needle 12g TW x 7.0" FDA UDI
Versa-Kath® 21g x 24" FDA UDI
Neo-Kath™ 24g Open End 12" FDA UDI
Flexible Introducer Cannula w/ 14g RW x 2.0" B Bevel FDA UDI
18g TW x 6.0" Tuohy Epidural Needle FDA UDI
Percutaneous Introducer w/ 14g RW x 4.7" B Bevel FDA UDI
22g RW x 4.5" Blunt Nerve Block Needle FDA UDI
G21 Open End Epidural Catheter 21g x 14" FDA UDI
R-F™ Cannula Coudé® B-Bevel 18g x 10cm w/ 10mm Active Tip FDA UDI
Spirol® 20g Closed End 24" FDA UDI
20g RW x 2.0" Stealth™Coudé® Needle w/ 6" Extension FDA UDI
Blunt Access Cannula w/ 18g XTW x 4.92" Sharp FDA UDI
20g TW X 3.5" Tuohy Needle for Injection FDA UDI
R-F™ Cannula Coudé® Blunt 20g x 10cm w/ 5mm Active Tip FDA UDI
Brevi-XL™ with Small Bore Connector 19g x 14" FDA UDI
R-F™ Cannula Coudé® B-Bevel 18g x 15cm w/ 10mm Active Tip FDA UDI
RF-A B Bevel 16g RW x 10cm x 10mm Straight Active Tip FDA UDI
20g TW x 6.0" Coudé® Blunt Nerve Block Needle FDA UDI
RX-2™ Epidural Needle Straight 13g x 6" w/ Snap on Wing FDA UDI
20g TW x 4.5" Tuohy Epidural Needle FDA UDI
20g TW x 3.5" Blunt Nerve Block Needle FDA UDI
20g X 6.0" Nerve Block Needle Quincke Tip FDA UDI
R-F™ Cannula Coudé® B-Bevel 16g x 10cm w/ 10mm Active Tip FDA UDI
22g TW x 8.0" Chiba Style Needle w/ Introducer FDA UDI
Nexus™ Epidural Catheter Connector 21g FDA UDI
RX Coudé® Epidural Needle 15g RW x 4.5" FDA UDI
20g HW x 2.75" Stealth™Coudé® Needle w/ 6" Extension FDA UDI
22g RW x 3.5" Bella-D® Coudé® Needle FDA UDI
RX-2™ Coudé® Epidural Needle 16g TW x 3.5" FDA UDI
22g RW x 3.5" Tuohy Epidural Needle FDA UDI
R-F™ Cannula Coudé® Blunt 22g TW x 10cm w/ 5mm Active Tip FDA UDI
RX Coudé® Epidural Needle 16g TW x 4.5" FDA UDI
22g RW x 7.0" Blunt Nerve Block Needle FDA UDI
RF-A B Bevel 16g RW x 10cm x 10mm Coudé® Active Tip FDA UDI
RX Coudé® Epidural Needle 12g TW x 7.0" FDA UDI
R-F™ Cannula B Bevel 16g TW x 15cm w/ 10mm Active Tip FDA UDI
RX Epidural Needle 13g TW x 4.0" FDA UDI
Blunt Access Cannula w/ 18g XTW x 2.8" Sharp FDA UDI
25g TW x 3.5" Quincke Spinal Needle w/ Introducer FDA UDI
R-F™ Cannula Coudé® B-Bevel 20g x 10cm w/ 10mm Active Tip FDA UDI
Versa-Kath® with Small Bore Connector 21g x 24" FDA UDI
20g RW x 6.0" Day Needle Bullet Tip Coudé® FDA UDI
Spirol® 20g Open End 36" FDA UDI
22g RW x 6.0" Coudé® Blunt Nerve Block Needle FDA UDI
R-F™ B Bevel 20g RW 10cm w/ 10mm Coudé® Active Tip FDA UDI
20g TW x 4.5" Coudé® Blunt Nerve Block Needle w/ Introducer FDA UDI
R-F™ Cannula Coudé® B Bevel 20g RW x 5cm w/ 5mm Active Tip FDA UDI
R-F™ Cannula Coudé® Bevel 20g RW x 10cm w/ 15mm Active Tip FDA UDI
Versa-Kath® 21g x 12" FDA UDI
Flexible Introducer Cannula w/ 17g x 3.5" Tuohy Metal Hub FDA UDI
Versa XLC 21g x 24" FDA UDI
20g TW x 6.0" Blunt Nerve Block Needle w/ Introducer FDA UDI
R-F™ Cannula Coudé® Blunt 22g TW x 15cm w/ 5mm Active Tip FDA UDI
22g RW X 3.5" Tuohy Needle for Injection FDA UDI
R-F™ Cannula B Bevel 20g TW x 5cm w/ 5mm Active Tip FDA UDI
22g X 4.5" Nerve Block Needle Quincke Tip FDA UDI
Nexus™ Epidural Catheter Connector 19g FDA UDI
R.K.™ 17g XTW x 3.5" FDA UDI
22g X 6.0" Nerve Block Needle Quincke Tip FDA UDI
18g TW x 3.5" Tuohy Epidural Needle FDA UDI
RX-2™ Coudé® Epidural Needle 14g TW x 4.0" FDA UDI
Spirol® 19g Open End 36" FDA UDI
Tun-L-XL™ 19g x 33.25" FDA UDI
Model / Reference
Nerve Block Needle EUDAMED
119-2080 EUDAMEDFDA UDI
131-2245 EUDAMEDFDA UDI
Spring Guide Epidural Catheter EUDAMED
201-2430 EUDAMEDFDA UDI
116-2235 EUDAMEDFDA UDI
RF Cannula EUDAMED
241-1610 EUDAMEDFDA UDI
Epidural Introducer Needle EUDAMED
125-2235T EUDAMEDFDA UDI
116-2035 EUDAMEDFDA UDI
126-2035 EUDAMEDFDA UDI
Flexible Epidural Introducer (FIC)/Blunt Cannula Access (BAC) EUDAMED
135-1857 EUDAMEDFDA UDI
159-2124 EUDAMEDFDA UDI
287-1610 EUDAMEDFDA UDI
286-2005 EUDAMEDFDA UDI
117-2080 EUDAMEDFDA UDI
115-2280 EUDAMEDFDA UDI
135-1420 EUDAMEDFDA UDI
117-2260 EUDAMEDFDA UDI
286-2205 EUDAMEDFDA UDI
169-2412 EUDAMEDFDA UDI
126-1860 EUDAMEDFDA UDI
123-2020 EUDAMEDFDA UDI
156-2112 EUDAMEDFDA UDI
125-1860T EUDAMEDFDA UDI
100-1415 EUDAMEDFDA UDI
131-2260 EUDAMEDFDA UDI
266-2210 EUDAMEDFDA UDI
123-2028 EUDAMEDFDA UDI
134-1455 EUDAMEDFDA UDI
107-1616 EUDAMEDFDA UDI
118-2045 EUDAMEDFDA UDI
231-1610 EUDAMEDFDA UDI
121-2235 EUDAMEDFDA UDI
Nearaxial Catheter Connector EUDAMED
1911-221 EUDAMEDFDA UDI
105-1516 EUDAMEDFDA UDI
116-2245 EUDAMEDFDA UDI
115-2235 EUDAMEDFDA UDI
109-1613 EUDAMEDFDA UDI
116-2060 EUDAMEDFDA UDI
135-1735 EUDAMEDFDA UDI
131-2060 EUDAMEDFDA UDI
282-1615 EUDAMEDFDA UDI
155-2343 EUDAMEDFDA UDI
107-1416 EUDAMEDFDA UDI
106-1616 EUDAMEDFDA UDI
288-2010 EUDAMEDFDA UDI
118-2060 EUDAMEDFDA UDI
116-2535 EUDAMEDFDA UDI
166-2024 EUDAMEDFDA UDI
156-2124 EUDAMEDFDA UDI
165-1936 EUDAMEDFDA UDI
117-2535 EUDAMEDFDA UDI
1911-219 EUDAMEDFDA UDI
267-2015 EUDAMEDFDA UDI
165-2036 EUDAMEDFDA UDI
261-2010 EUDAMEDFDA UDI
106-1313 EUDAMEDFDA UDI
122-2060 EUDAMEDFDA UDI
125-2045T EUDAMEDFDA UDI
130-2535 EUDAMEDFDA UDI
287-1815 EUDAMEDFDA UDI
116-2270 EUDAMEDFDA UDI
134-1435 EUDAMEDFDA UDI
161-2124 EUDAMEDFDA UDI
284-2010 EUDAMED
153-2340 EUDAMEDFDA UDI
164-1936 EUDAMEDFDA UDI
135-1837 EUDAMEDFDA UDI
106-1712 EUDAMEDFDA UDI
126-2225 EUDAMEDFDA UDI
156-2118 EUDAMEDFDA UDI
126-1735 EUDAMEDFDA UDI
257-1810 EUDAMEDFDA UDI
135-1825 EUDAMEDFDA UDI
106-1613 EUDAMEDFDA UDI
193-2036 EUDAMEDFDA UDI
287-2015 EUDAMEDFDA UDI
105-1416 EUDAMEDFDA UDI
231-2010 EUDAMEDFDA UDI
158-2114 EUDAMEDFDA UDI
287-1810 EUDAMEDFDA UDI
266-2010 EUDAMEDFDA UDI
105-1515 EUDAMEDFDA UDI
243-1610 EUDAMEDFDA UDI
105-1712 EUDAMEDFDA UDI
287-2010 EUDAMEDFDA UDI
233-2010 EUDAMEDFDA UDI
117-2045 EUDAMEDFDA UDI
266-2215 EUDAMEDFDA UDI
126-2235 EUDAMEDFDA UDI
281-2005 EUDAMEDFDA UDI
100-1417 EUDAMEDFDA UDI
125-1835T EUDAMEDFDA UDI
107-1314 EUDAMEDFDA UDI
155-2540 EUDAMEDFDA UDI
Description
22g TW x 3.5" Chiba Style Needle FDA UDI
22g RW X 2.5" Tuohy Needle for Injection FDA UDI
Spirol® 19g Closed End Styletted 36" FDA UDI
25g RW x 3.5" Coudé® Blunt Nerve Block Needle w/ Introducer FDA UDI
25g RW x 3.5" Blunt Nerve Block Needle w/ Introducer FDA UDI
R-F™ B Bevel 16g RW 10cm w/ 10mm Straight Active Tip FDA UDI
Percutaneous Introducer w/ 14g RW x 2.7" B Bevel FDA UDI
R-F™ Cannula Coudé® Blunt 20g x 15cm w/ 10mm Active Tip FDA UDI
22g RW x 3.5" Blunt Nerve Block Needle FDA UDI
RX Epidural Needle 16g TW x 6.0" FDA UDI
20g TW x 4.5" Coudé® Blunt Nerve Block Needle FDA UDI
20g TW x 8.0" Coudé® Blunt Nerve Block Needle w/ Introducer FDA UDI
R.K.™ 15g TW x 3.5" FDA UDI
R-F™ Cannula Blunt 20g TW x 10cm w/ 5mm Active Tip FDA UDI
Versa-Kath® 21g x 18" FDA UDI
17g TW X 3.5" Tuohy Needle for Injection FDA UDI
R-F™ Cobra Injector Cannula Coudé® 18g x 10cm w/ 10mm Active Tip FDA UDI
RX-2™ Coudé® Epidural Needle 13g TW x 6.0" FDA UDI
Blunt Access Cannula 18g XTW x 1.8" Sharp FDA UDI
Neo-Kath™ 24g x 30" Caudal Set FDA UDI
Brevi-STF® 19g x 14" FDA UDI
18g TW X 6.0" Tuohy Needle for Injection FDA UDI
RX Epidural Needle 13g TW x 6.0" FDA UDI
Spirol® Close End 20g x 36" Short Crawford Set, Styletted FDA UDI
R-F™ Cannula Coudé® B-Bevel 20g x 15cm w/ 10mm Active Tip FDA UDI
RX Coudé® Epidural Needle 16g TW x 3.5" FDA UDI
R-F™ B Bevel 20g RW 10cm w/ 10mm Straight Active Tip FDA UDI
R-F™ Cannula Coudé® B-Bevel 22g x 5cm w/ 5mm Active Tip FDA UDI
RX Epidural Needle 12g TW x 7.0" FDA UDI
Versa-Kath® 21g x 24" FDA UDI
Neo-Kath™ 24g Open End 12" FDA UDI
Flexible Introducer Cannula w/ 14g RW x 2.0" B Bevel FDA UDI
18g TW x 6.0" Tuohy Epidural Needle FDA UDI
Percutaneous Introducer w/ 14g RW x 4.7" B Bevel FDA UDI
22g RW x 4.5" Blunt Nerve Block Needle FDA UDI
G21 Open End Epidural Catheter 21g x 14" FDA UDI
R-F™ Cannula Coudé® B-Bevel 18g x 10cm w/ 10mm Active Tip FDA UDI
Spirol® 20g Closed End 24" FDA UDI
20g RW x 2.0" Stealth™Coudé® Needle w/ 6" Extension FDA UDI
Blunt Access Cannula w/ 18g XTW x 4.92" Sharp FDA UDI
20g TW X 3.5" Tuohy Needle for Injection FDA UDI
R-F™ Cannula Coudé® Blunt 20g x 10cm w/ 5mm Active Tip FDA UDI
Brevi-XL™ with Small Bore Connector 19g x 14" FDA UDI
R-F™ Cannula Coudé® B-Bevel 18g x 15cm w/ 10mm Active Tip FDA UDI
RF-A B Bevel 16g RW x 10cm x 10mm Straight Active Tip FDA UDI
20g TW x 6.0" Coudé® Blunt Nerve Block Needle FDA UDI
RX-2™ Epidural Needle Straight 13g x 6" w/ Snap on Wing FDA UDI
20g TW x 4.5" Tuohy Epidural Needle FDA UDI
20g TW x 3.5" Blunt Nerve Block Needle FDA UDI
20g X 6.0" Nerve Block Needle Quincke Tip FDA UDI
R-F™ Cannula Coudé® B-Bevel 16g x 10cm w/ 10mm Active Tip FDA UDI
22g TW x 8.0" Chiba Style Needle w/ Introducer FDA UDI
Nexus™ Epidural Catheter Connector 21g FDA UDI
RX Coudé® Epidural Needle 15g RW x 4.5" FDA UDI
20g HW x 2.75" Stealth™Coudé® Needle w/ 6" Extension FDA UDI
22g RW x 3.5" Bella-D® Coudé® Needle FDA UDI
RX-2™ Coudé® Epidural Needle 16g TW x 3.5" FDA UDI
22g RW x 3.5" Tuohy Epidural Needle FDA UDI
R-F™ Cannula Coudé® Blunt 22g TW x 10cm w/ 5mm Active Tip FDA UDI
RX Coudé® Epidural Needle 16g TW x 4.5" FDA UDI
22g RW x 7.0" Blunt Nerve Block Needle FDA UDI
RF-A B Bevel 16g RW x 10cm x 10mm Coudé® Active Tip FDA UDI
RX Coudé® Epidural Needle 12g TW x 7.0" FDA UDI
R-F™ Cannula B Bevel 16g TW x 15cm w/ 10mm Active Tip FDA UDI
RX Epidural Needle 13g TW x 4.0" FDA UDI
Blunt Access Cannula w/ 18g XTW x 2.8" Sharp FDA UDI
25g TW x 3.5" Quincke Spinal Needle w/ Introducer FDA UDI
R-F™ Cannula Coudé® B-Bevel 20g x 10cm w/ 10mm Active Tip FDA UDI
Versa-Kath® with Small Bore Connector 21g x 24" FDA UDI
20g RW x 6.0" Day Needle Bullet Tip Coudé® FDA UDI
Spirol® 20g Open End 36" FDA UDI
22g RW x 6.0" Coudé® Blunt Nerve Block Needle FDA UDI
R-F™ B Bevel 20g RW 10cm w/ 10mm Coudé® Active Tip FDA UDI
20g TW x 4.5" Coudé® Blunt Nerve Block Needle w/ Introducer FDA UDI
R-F™ Cannula Coudé® B Bevel 20g RW x 5cm w/ 5mm Active Tip FDA UDI
R-F™ Cannula Coudé® Bevel 20g RW x 10cm w/ 15mm Active Tip FDA UDI
Versa-Kath® 21g x 12" FDA UDI
Flexible Introducer Cannula w/ 17g x 3.5" Tuohy Metal Hub FDA UDI
Versa XLC 21g x 24" FDA UDI
20g TW x 6.0" Blunt Nerve Block Needle w/ Introducer FDA UDI
R-F™ Cannula Coudé® Blunt 22g TW x 15cm w/ 5mm Active Tip FDA UDI
22g RW X 3.5" Tuohy Needle for Injection FDA UDI
R-F™ Cannula B Bevel 20g TW x 5cm w/ 5mm Active Tip FDA UDI
22g X 4.5" Nerve Block Needle Quincke Tip FDA UDI
Nexus™ Epidural Catheter Connector 19g FDA UDI
R.K.™ 17g XTW x 3.5" FDA UDI
22g X 6.0" Nerve Block Needle Quincke Tip FDA UDI
18g TW x 3.5" Tuohy Epidural Needle FDA UDI
RX-2™ Coudé® Epidural Needle 14g TW x 4.0" FDA UDI
Spirol® 19g Open End 36" FDA UDI
Tun-L-XL™ 19g x 33.25" FDA UDI

Identifiers

Catalog Number
115-2235 FDA UDI
126-2225 FDA UDI
164-1936 FDA UDI
117-2535 FDA UDI
116-2535 FDA UDI
231-1610 FDA UDI
134-1435 FDA UDI
267-2015 FDA UDI
106-1616 FDA UDI
118-2045 FDA UDI
117-2080 FDA UDI
100-1415 FDA UDI
261-2010 FDA UDI
156-2118 FDA UDI
126-1735 FDA UDI
257-1810 FDA UDI
107-1616 FDA UDI
135-1825 FDA UDI
201-2430 FDA UDI
155-2343 FDA UDI
126-1860 FDA UDI
106-1613 FDA UDI
193-2036 FDA UDI
287-2015 FDA UDI
119-2080 FDA UDI
105-1416 FDA UDI
231-2010 FDA UDI
286-2205 FDA UDI
106-1712 FDA UDI
156-2124 FDA UDI
169-2412 FDA UDI
135-1420 FDA UDI
125-1860T FDA UDI
134-1455 FDA UDI
116-2245 FDA UDI
158-2114 FDA UDI
287-1810 FDA UDI
166-2024 FDA UDI
135-1857 FDA UDI
126-2035 FDA UDI
266-2010 FDA UDI
153-2340 FDA UDI
287-1815 FDA UDI
241-1610 FDA UDI
118-2060 FDA UDI
109-1613 FDA UDI
125-2045T FDA UDI
131-2060 FDA UDI
287-1610 FDA UDI
115-2280 FDA UDI
1911-221 FDA UDI
105-1515 FDA UDI
123-2028 FDA UDI
121-2235 FDA UDI
107-1416 FDA UDI
125-2235T FDA UDI
266-2210 FDA UDI
105-1516 FDA UDI
243-1610 FDA UDI
105-1712 FDA UDI
106-1313 FDA UDI
135-1837 FDA UDI
130-2535 FDA UDI
287-2010 FDA UDI
159-2124 FDA UDI
122-2060 FDA UDI
165-2036 FDA UDI
117-2260 FDA UDI
233-2010 FDA UDI
117-2045 FDA UDI
286-2005 FDA UDI
288-2010 FDA UDI
156-2112 FDA UDI
135-1735 FDA UDI
161-2124 FDA UDI
116-2060 FDA UDI
266-2215 FDA UDI
126-2235 FDA UDI
281-2005 FDA UDI
131-2245 FDA UDI
1911-219 FDA UDI
100-1417 FDA UDI
131-2260 FDA UDI
125-1835T FDA UDI
107-1314 FDA UDI
165-1936 FDA UDI
155-2540 FDA UDI
Primary DI / UDI-DI
00818788023629 EUDAMEDFDA UDI
00818788023438 EUDAMEDFDA UDI
00818788021724 EUDAMEDFDA UDI
00818788022899 EUDAMEDFDA UDI
00818788023094 EUDAMEDFDA UDI
00818788020857 EUDAMEDFDA UDI
00818788022875 EUDAMEDFDA UDI
00818788023353 EUDAMEDFDA UDI
00818788020987 EUDAMEDFDA UDI
00818788023568 EUDAMEDFDA UDI
00818788022592 EUDAMEDFDA UDI
00818788022530 EUDAMEDFDA UDI
00818788020505 EUDAMEDFDA UDI
00818788020406 EUDAMEDFDA UDI
00818788020932 EUDAMEDFDA UDI
00818788020598 EUDAMEDFDA UDI
00818788022561 EUDAMEDFDA UDI
00818788022158 EUDAMEDFDA UDI
00818788023339 EUDAMEDFDA UDI
00818788022912 EUDAMEDFDA UDI
00818788021120 EUDAMEDFDA UDI
00818788020819 EUDAMEDFDA UDI
00818788020000 EUDAMEDFDA UDI
00818788023445 EUDAMEDFDA UDI
00818788021991 EUDAMEDFDA UDI
00818788020758 EUDAMEDFDA UDI
00818788020925 EUDAMEDFDA UDI
00818788023674 EUDAMEDFDA UDI
00818788020611 EUDAMEDFDA UDI
00818788023155 EUDAMEDFDA UDI
00818788020697 EUDAMEDFDA UDI
00818788021540 EUDAMEDFDA UDI
00818788020123 EUDAMEDFDA UDI
00818788020567 EUDAMEDFDA UDI
00818788020383 EUDAMEDFDA UDI
00818788022080 EUDAMEDFDA UDI
00818788020420 EUDAMEDFDA UDI
00818788020956 EUDAMEDFDA UDI
00818788023407 EUDAMEDFDA UDI
00818788023667 EUDAMEDFDA UDI
00818788021076 EUDAMEDFDA UDI
00818788020352 EUDAMEDFDA UDI
00818788020314 EUDAMEDFDA UDI
00818788022134 EUDAMEDFDA UDI
00818788020628 EUDAMEDFDA UDI
00818788020482 EUDAMEDFDA UDI
00818788021250 EUDAMEDFDA UDI
00818788021137 EUDAMEDFDA UDI
00818788021229 EUDAMEDFDA UDI
00818788020604 EUDAMEDFDA UDI
00818788021533 EUDAMEDFDA UDI
00818788022028 EUDAMEDFDA UDI
00818788021236 EUDAMEDFDA UDI
00818788021786 EUDAMEDFDA UDI
00818788020222 EUDAMEDFDA UDI
00818788020734 EUDAMEDFDA UDI
00818788020833 EUDAMEDFDA UDI
00818788020871 EUDAMEDFDA UDI
00818788022622 EUDAMEDFDA UDI
00818788022905 EUDAMEDFDA UDI
00818788020918 EUDAMEDFDA UDI
00818788021762 EUDAMEDFDA UDI
00818788022967 EUDAMED
00818788023537 EUDAMEDFDA UDI
00818788021182 EUDAMEDFDA UDI
00818788020970 EUDAMEDFDA UDI
00818788020321 EUDAMEDFDA UDI
00818788023384 EUDAMEDFDA UDI
00818788022141 EUDAMEDFDA UDI
00818788023285 EUDAMEDFDA UDI
00818788021496 EUDAMEDFDA UDI
00818788020963 EUDAMEDFDA UDI
00818788020291 EUDAMEDFDA UDI
00818788022264 EUDAMEDFDA UDI
00818788022646 EUDAMEDFDA UDI
00818788020093 EUDAMEDFDA UDI
00818788023148 EUDAMEDFDA UDI
00818788020772 EUDAMEDFDA UDI
00818788022615 EUDAMEDFDA UDI
00818788021960 EUDAMEDFDA UDI
00818788020116 EUDAMEDFDA UDI
00818788023117 EUDAMEDFDA UDI
00818788020185 EUDAMEDFDA UDI
00818788022639 EUDAMEDFDA UDI
00818788023162 EUDAMEDFDA UDI
00818788020499 EUDAMEDFDA UDI
00818788022004 EUDAMEDFDA UDI
00818788023391 EUDAMEDFDA UDI
00818788022417 EUDAMEDFDA UDI
00818788020024 EUDAMEDFDA UDI
00818788020802 EUDAMEDFDA UDI
00818788020338 EUDAMEDFDA UDI
00818788021106 EUDAMEDFDA UDI
Basic UDI-DI
081878802NBNLS EUDAMED
081878802SGECH6 EUDAMED
081878802RFCannulaRS EUDAMED
081878802EINL2 EUDAMED
081878802FEIKH EUDAMED
081878802CathConnectorQW EUDAMED
510(k) Number
K022029 FDA UDI
K030562 FDA UDI
K981329 FDA UDI
K041843 FDA UDI
K041021 FDA UDI
K051860 FDA UDI
K053318 FDA UDI
K072005 FDA UDI
K954584 FDA UDI
K051171 FDA UDI
K023140 FDA UDI
FDA Product Code
BSP FDA UDI
BSO FDA UDI
GXI FDA UDI
MIA FDA UDI
CAZ FDA UDI
EMDN Code
A019001 BLUNT NEEDLES EUDAMED
A0199 NEEDLES - OTHER EUDAMED
N010401 PERIPHERAL NERVOUS SYSTEM CATHETERS AND KITS EUDAMED
K02030106 RADIOFREQUENCY SURGERY CANNULAS, SINGLE-USE EUDAMED
A01030102 EPIDURAL ANAESTHESIA NEEDLES AND KITS EUDAMED
A019013 PERCUTANEOUS NEEDLES EUDAMED
A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED
GMDN Term
Peripheral nerve-block sharp needle FDA UDI
Epidural needle, non-threaded FDA UDI
Epidural anaesthesia set, non-medicated FDA UDI
Peripheral nerve-block blunt needle access cannula FDA UDI
Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Non-vascular catheter introduction set FDA UDI
Peripheral nerve-block blunt needle FDA UDI
Luer/Luer linear connector, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
868.5150 FDA UDI
868.5120 FDA UDI
882.4725 FDA UDI
868.5140 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

Yes

EUDAMEDEUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDIFDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 3.5 Inch FDA UDI
Needle Gauge — 22 Gauge FDA UDI
Length — 2.5 Inch FDA UDI
Length — 36 Inch FDA UDI
Catheter Gauge — 3.2 French FDA UDI
Needle Gauge — 25 Gauge FDA UDI
Needle Gauge — 16 Gauge FDA UDI
Length — 10 Millimeter FDA UDI
Length — 10 Centimeter FDA UDI
Needle Gauge — 14 Gauge FDA UDI
Length — 15 Centimeter FDA UDI
Needle Gauge — 20 Gauge FDA UDI
Length — 6 Inch FDA UDI
Length — 4.5 Inch FDA UDI
Length — 8 Inch FDA UDI
Needle Gauge — 15 Gauge FDA UDI
Length — 5 Millimeter FDA UDI
Catheter Gauge — 2.4 French FDA UDI
Length — 21 Inch FDA UDI
Needle Gauge — 17 Gauge FDA UDI
Needle Gauge — 18 Gauge FDA UDI
Needle Gauge — 13 Gauge FDA UDI
Length — 30 Inch FDA UDI
Catheter Gauge — 1.7 French FDA UDI
Length — 14 Inch FDA UDI
Catheter Gauge — 2.7 French FDA UDI
Length — 5 Centimeter FDA UDI
Needle Gauge — 12 Gauge FDA UDI
Length — 7 Inch FDA UDI
Length — 24 Inch FDA UDI
Length — 12 Inch FDA UDI
Length — 2 Inch FDA UDI
Length — 5.5 Inch FDA UDI
Length — 2.0 Inch FDA UDI
Length — 5.7 Inch FDA UDI
Length — 2.75 Inch FDA UDI
Length — 7.0 Inch FDA UDI
Length — 10 Inch FDA UDI
Length — 4 Inch FDA UDI
Length — 3.7 Inch FDA UDI
Length — 15 Millimeter FDA UDI
Length — 33.25 Inch FDA UDI

Epimed International, Inc. by Epimed International, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Epimed International, Inc.
EUDAMED SRN
US-MF-000010774
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (251)

  • EUDAMED 25a4f73c-b513-43c4-9b56-93deb59c77ae 61 fields · synced Sep 30, 2026
  • EUDAMED 43d4cecc-88a0-408a-a4b4-ce3e21957995 61 fields · synced May 16, 2026
  • EUDAMED 30cdd435-8dc4-4675-8c63-ab11ee6fd439 61 fields · synced May 16, 2026
  • EUDAMED d87cb16e-b995-4bea-b0cd-f7e242ba8e90 61 fields · synced May 16, 2026
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  • EUDAMED b9a7bc60-59bd-4808-a2f7-7ed62033c2cb 61 fields · synced May 18, 2026
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  • EUDAMED c36b9470-75b7-41ee-9484-1d31450c76a1 61 fields · synced May 18, 2026
  • EUDAMED 34fadb8a-87df-4e59-bb91-0042c4161673 61 fields · synced May 18, 2026
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  • EUDAMED 2ef29bb9-2a5c-4745-afa3-f94de51c3a99 61 fields · synced May 18, 2026
  • EUDAMED 81acc1eb-ce49-49a1-ab85-b754486d78c9 61 fields · synced May 18, 2026
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  • EUDAMED 676e9649-ca4a-49bd-ad13-a9eea9b22679 61 fields · synced May 18, 2026
  • FDA UDI eb7c7103-b3d5-463f-be25-3176aa012651 38 fields · synced May 26, 2026
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  • FDA UDI c3ff7961-1046-47a3-8a7d-79260025cc17 38 fields · synced May 27, 2026
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  • FDA UDI bed2a990-dc93-45bb-bc2a-889fdcd596d6 38 fields · synced May 29, 2026
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