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Disposable Sclerotherapy Needle

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref AG-5314-2412-2506Ref AG-5318-2423-2504MRef AG-5316-2427-2304MRef AG-5318-2427-2406MRef AG-5311-2416-1904Ref AG-5314-2423-2306Ref AG-5313-2423-1904MRef AG-5082-2423-2304Ref AG-5318-2416-1904MRef AG-5314-2412-2104Ref AG-5314-2416-2106MRef AG-5314-2412-1906Ref AG-5084-2416-2206Ref AG-5318-2420-2304MRef AG-5083-2423-2504Ref AG-5314-2420-2106MRef AG-5318-2427-1906MRef AG-5314-2423-1906Ref AG-5084-2416-2204Ref AG-5314-2412-2406MRef AG-5314-2427-2306Ref AG-5318-2427-2104MRef AG-5085-2420-2406Ref AG-5316-2427-1906MRef AG-5311-2416-1904MRef AG-5317-2420-2106MRef AG-5314-2427-1904Ref AG-5314-2427-2104Ref AG-5314-2427-2504MRef AG-5314-2412-2406Ref AG-5314-2423-2504MRef AG-5084-2427-2206Ref AG-5314-2427-2404Ref AG-5314-2420-2304Ref AG-5314-2420-2504Ref AG-5317-2420-2404MRef AG-5317-2412-2504MRef AG-5311-2420-1906Ref AG-5317-2427-2104MRef AG-5314-2427-2304MRef AG-5317-2412-2306MRef AG-5314-2416-2104Ref AG-5314-2420-2106Ref AG-5313-2427-2506MRef AG-5313-2412-2106MRef AG-5317-2420-2104MRef AG-5311-2427-2504MRef AG-5314-2416-2104MRef AG-5317-2420-2504MRef AG-5317-2423-2304MRef AG-5317-2412-1904M

by Hangzhou AGS MedTech Co., Ltd.

Identity

Device Name
Disposable Sclerotherapy Needle EUDAMED
Model / Reference
AG-5314-2412-2506 EUDAMED
AG-5318-2423-2504M EUDAMED
AG-5316-2427-2304M EUDAMED
AG-5318-2427-2406M EUDAMED
AG-5311-2416-1904 EUDAMED
AG-5314-2423-2306 EUDAMED
AG-5313-2423-1904M EUDAMED
AG-5082-2423-2304 EUDAMED
AG-5318-2416-1904M EUDAMED
AG-5314-2412-2104 EUDAMED
AG-5314-2416-2106M EUDAMED
AG-5314-2412-1906 EUDAMED
AG-5084-2416-2206 EUDAMED
AG-5318-2420-2304M EUDAMED
AG-5083-2423-2504 EUDAMED
AG-5314-2420-2106M EUDAMED
AG-5318-2427-1906M EUDAMED
AG-5314-2423-1906 EUDAMED
AG-5084-2416-2204 EUDAMED
AG-5314-2412-2406M EUDAMED
AG-5314-2427-2306 EUDAMED
AG-5318-2427-2104M EUDAMED
AG-5085-2420-2406 EUDAMED
AG-5316-2427-1906M EUDAMED
AG-5311-2416-1904M EUDAMED
AG-5317-2420-2106M EUDAMED
AG-5314-2427-1904 EUDAMED
AG-5314-2427-2104 EUDAMED
AG-5314-2427-2504M EUDAMED
AG-5314-2412-2406 EUDAMED
AG-5314-2423-2504M EUDAMED
AG-5084-2427-2206 EUDAMED
AG-5314-2427-2404 EUDAMED
AG-5314-2420-2304 EUDAMED
AG-5314-2420-2504 EUDAMED
AG-5317-2420-2404M EUDAMED
AG-5317-2412-2504M EUDAMED
AG-5311-2420-1906 EUDAMED
AG-5317-2427-2104M EUDAMED
AG-5314-2427-2304M EUDAMED
AG-5317-2412-2306M EUDAMED
AG-5314-2416-2104 EUDAMED
AG-5314-2420-2106 EUDAMED
AG-5313-2427-2506M EUDAMED
AG-5313-2412-2106M EUDAMED
AG-5317-2420-2104M EUDAMED
AG-5311-2427-2504M EUDAMED
AG-5314-2416-2104M EUDAMED
AG-5317-2420-2504M EUDAMED
AG-5317-2423-2304M EUDAMED
AG-5317-2412-1904M EUDAMED

Identifiers

Primary DI / UDI-DI
06959664933862 EUDAMED
06959664943960 EUDAMED
06959664942574 EUDAMED
06959664943922 EUDAMED
06959664931622 EUDAMED
06959664933497 EUDAMED
06959664941423 EUDAMED
06959664903360 EUDAMED
06959664943441 EUDAMED
06959664933015 EUDAMED
06959664933176 EUDAMED
06959664932865 EUDAMED
06959664908389 EUDAMED
06959664943755 EUDAMED
06959664903384 EUDAMED
06959664933183 EUDAMED
06959664943526 EUDAMED
06959664932896 EUDAMED
06959664908334 EUDAMED
06959664933763 EUDAMED
06959664942123 EUDAMED
06959664943571 EUDAMED
06959664900338 EUDAMED
06959664942321 EUDAMED
06959664931721 EUDAMED
06959664943007 EUDAMED
06959664941997 EUDAMED
06959664942031 EUDAMED
06959664942215 EUDAMED
06959664933664 EUDAMED
06959664933947 EUDAMED
06959664908402 EUDAMED
06959664942154 EUDAMED
06959664933435 EUDAMED
06959664933831 EUDAMED
06959664943250 EUDAMED
06959664943335 EUDAMED
06959664931684 EUDAMED
06959664942970 EUDAMED
06959664942130 EUDAMED
06959664943182 EUDAMED
06959664933022 EUDAMED
06959664933084 EUDAMED
06959664941980 EUDAMED
06959664941546 EUDAMED
06959664942956 EUDAMED
06959664929742 EUDAMED
06959664933121 EUDAMED
06959664943359 EUDAMED
06959664943168 EUDAMED
06959664942833 EUDAMED
Basic UDI-DI
695966495311000013Y EUDAMED
EMDN Code
G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Disposable Sclerotherapy Needle by Hangzhou AGS MedTech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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

Manufacturer

Manufacturer
Hangzhou AGS MedTech Co., Ltd.
EUDAMED SRN
CN-MF-000011718
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (52)

  • EUDAMED 0d1af911-f963-4fc3-9c65-573909305b19 61 fields · synced Oct 5, 2026
  • EUDAMED 2f02a0c6-3896-4f4e-b845-696195a4d696 61 fields · synced May 11, 2026
  • EUDAMED 388d4182-19cf-41e7-87d6-66f75b6e2408 61 fields · synced May 11, 2026
  • EUDAMED 6ba2fde5-58d3-4195-b589-99d19a7bfd69 61 fields · synced May 11, 2026
  • EUDAMED 8e07f3a7-7035-4b39-b528-3903d6d49d6b 61 fields · synced May 11, 2026
  • EUDAMED b8857860-359f-4b0f-9d31-1e178c72a938 61 fields · synced May 11, 2026
  • EUDAMED 182d7956-bbc1-42da-b0a7-8ef0c969d6da 61 fields · synced May 11, 2026
  • EUDAMED 16a02ba4-5ed2-4680-9672-bbfe1a3bd51b 61 fields · synced May 11, 2026
  • EUDAMED 71d5b660-bb7b-4987-8297-7702c7a90eca 61 fields · synced May 16, 2026
  • EUDAMED 785bd500-7ffa-4c43-9b6c-215e5a1b501b 61 fields · synced May 16, 2026
  • EUDAMED 44cce59e-3769-4bd8-b99f-9e749b13edf1 61 fields · synced May 16, 2026
  • EUDAMED 25abcaf5-ab6c-4a8e-9717-43a5ce74e390 61 fields · synced May 16, 2026
  • EUDAMED 67c02c22-59b2-4e62-af3f-0bbcd65b387e 61 fields · synced May 16, 2026
  • EUDAMED 67adb0e8-f681-475b-a877-e705b950effe 61 fields · synced May 16, 2026
  • EUDAMED c337d454-fb71-4a38-8d40-94c51991f07d 61 fields · synced May 16, 2026
  • EUDAMED 7bfd16fa-aea0-4d41-9327-925d0fa8f739 61 fields · synced May 16, 2026
  • EUDAMED 24864465-5091-4b7a-bc94-37ec8a5040ac 61 fields · synced May 16, 2026
  • EUDAMED 55936759-7a74-4618-ae56-e3dfc02c9f8c 61 fields · synced May 16, 2026
  • EUDAMED 41f34ccf-49eb-4993-9b26-4c318a83b87b 61 fields · synced May 16, 2026
  • EUDAMED 94eefe9e-fc34-4ea6-99f0-a328e30e0d51 61 fields · synced May 16, 2026
  • EUDAMED 06408e91-285a-4285-9a8d-0761023cdef1 61 fields · synced May 16, 2026
  • EUDAMED 986c8613-ca21-4934-8f02-e65d21b5d12d 61 fields · synced May 16, 2026
  • EUDAMED aa6c35a6-1c7d-4247-9d6b-6246fb41e687 61 fields · synced May 16, 2026
  • EUDAMED 9e11aa82-b4d4-4b20-ad28-8cfd25a811bf 61 fields · synced May 16, 2026
  • EUDAMED 21df7c5e-18c2-4fa8-b68b-6fcfe356b303 61 fields · synced May 16, 2026
  • EUDAMED 1463b5c0-4ed1-431a-a647-50520fdbcbdd 61 fields · synced May 16, 2026
  • EUDAMED cf1a8704-80de-4f17-98a3-d221b893dc7b 61 fields · synced May 16, 2026
  • EUDAMED 821c1db2-42d9-4c78-836f-6e749d157844 61 fields · synced May 16, 2026
  • EUDAMED 34188ff9-83f8-4f23-9f77-0add199de020 61 fields · synced May 16, 2026
  • EUDAMED f114eacc-b5d5-4593-a0b8-23c414059469 61 fields · synced May 16, 2026
  • EUDAMED a4d46098-f985-488e-a51d-332da7178bbf 61 fields · synced May 16, 2026
  • EUDAMED b6af7636-2350-4c1a-9e31-8ca120c49530 61 fields · synced May 16, 2026
  • EUDAMED 4d82bcef-0f8d-4705-9176-0a37901f651a 61 fields · synced May 17, 2026
  • EUDAMED 228140c3-8a68-415a-b9da-4c5a4570d115 61 fields · synced May 17, 2026
  • EUDAMED be474e02-0c1f-4846-9cbc-1dd36d366458 61 fields · synced May 17, 2026
  • EUDAMED 29df3a27-dfad-477f-b0c9-87dd5970a8fb 61 fields · synced May 17, 2026
  • EUDAMED 6ccbf6b8-75a6-43ce-aa9a-86e114083f2d 61 fields · synced May 17, 2026
  • EUDAMED 016e3473-9a20-4df6-9c2d-4e1a07297e2a 61 fields · synced May 17, 2026
  • EUDAMED afafa8ed-e153-4faa-8557-8e9057728d09 61 fields · synced May 17, 2026
  • EUDAMED 323294ae-d5ff-4925-a4b3-d89a92540f15 61 fields · synced May 17, 2026
  • EUDAMED 7908b57e-3be1-42a8-8edd-c29d16f22820 61 fields · synced May 17, 2026
  • EUDAMED 189575bb-4915-4588-b41e-794689b336b4 61 fields · synced May 17, 2026
  • EUDAMED 553d5534-971d-4d4e-b4e9-3e56677959fe 61 fields · synced May 17, 2026
  • EUDAMED f428852d-6975-4fb6-815b-c9743d6cd46b 61 fields · synced May 17, 2026
  • EUDAMED dac5ac1d-65c4-4bf8-8f96-80893c9912b4 61 fields · synced May 17, 2026
  • EUDAMED ff880394-fd8b-4099-9855-ad82053c6e5b 61 fields · synced May 17, 2026
  • EUDAMED 445071cb-0e90-4ec2-9b39-721add1ce9e3 61 fields · synced May 17, 2026
  • EUDAMED a213bd4d-0dcb-4fc9-b417-4846927727c7 61 fields · synced May 17, 2026
  • EUDAMED a6ec35b6-1005-45eb-8180-ffa38f9e4072 61 fields · synced May 17, 2026
  • EUDAMED c2cb16b3-e94f-4b95-a6ca-340c3f924c1f 61 fields · synced May 17, 2026
  • EUDAMED c39bf623-b35c-4916-bfa7-f47893bdc858 61 fields · synced May 17, 2026
  • FDA 510(k) K190032 1 fields · synced May 18, 2026