Identity
- Trade Name
- Unifine Pentips EUDAMED
- Device Name
- Unifine Pentips EUDAMED
- Model / Reference
- P002775A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189277510 EUDAMED
- Basic UDI-DI
- 5016189OVALEAPPENTIPSZJ EUDAMED
- EMDN Code
- A018006 HYPODERMIC NEEDLES PEN INJECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Unifine Pentips by Owen Mumford 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 | 5016189OVALEAPPENTIPSZJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Owen Mumford Ltd
- EUDAMED SRN
- GB-MF-000021000
- Authorised Representative
- Owen Mumford GmbH DE-AR-000020700
Sources (1)
- EUDAMED 02e188fb-4525-4b22-a1c2-104749892e83 61 fields · synced May 23, 2026