Identity
- Device Name
- Sterile Pen Needles EUDAMED
- Model / Reference
- 29G,30G,31G,32G EUDAMED31G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976523540115 EUDAMED
- Basic UDI-DI
- 697652354PZ001MV EUDAMED
- EMDN Code
- A01010199 HYPODERMIC NEEDLES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Sterile Pen Needles by Shandong Caremed Medical Products Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697652354PZ001MV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Caremed Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000033413
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8eb04181-29a4-4627-8020-f50084b5b4eb 61 fields · synced Jun 18, 2026