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Safety Needle
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 7527942064Model 23G x 1"; 22G x 1½”; 22G x 1” TW; 22G x 1½” TW; 20G x 1½” TW
Identity
- Trade Name
- Safety Needle EUDAMEDFDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Safety Needle EUDAMED
- Model / Reference
- 7527942064 EUDAMEDFDA UDI23G x 1"; 22G x 1½”; 22G x 1” TW; 22G x 1½” TW; 20G x 1½” TW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907527942064 EUDAMEDFDA UDI
- Basic UDI-DI
- 05907527942SafetyNeedleYQ EUDAMED
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Belgium 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA 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
Category: Hypodermic needle, single-use
Safety Needle by Steripack Medical Poland Sp Z O O — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Steripack Medical Poland Sp Z O O
Sources (2)
- FDA UDI dd7eb33a-1b90-4086-bda3-220e0c1a6f02 32 fields · synced Jun 19, 2026
- EUDAMED 172919c8-ddcb-46f7-929f-034432af600f 61 fields · synced Jun 19, 2026