Identity
- Device Name
- safety pen needle EUDAMED
- Model / Reference
- ST-PN31-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965291494 EUDAMED
- Basic UDI-DI
- 697122740SPNRK EUDAMED
- Unit of Use DI
- 86975965291490 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS 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
safety pen needle by Promisemed Hangzhou Meditech 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
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220129 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K202682 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697122740SPNRK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 6525a9e9-fbd6-4070-a899-e165e0f9efed 61 fields · synced Oct 7, 2026
- FDA 510(k) K220129 1 fields · synced May 18, 2026