Identity
- Trade Name
- Unistik 3 Extra (21G 2.0mm) EUDAMED
- Device Name
- Unistik 3 EUDAMED
- Model / Reference
- 001196 EUDAMEDAT1012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189119612 EUDAMED05016189101211 EUDAMED
- Basic UDI-DI
- 5016189UNISTIK3EF EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE 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
Category: Blood lancet, single-use
Unistik 3 Extra (21G 2.0mm) by Owen Mumford Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5016189UNISTIK3EF | 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 (2)
- EUDAMED 0ad6d10c-9457-4e40-aabd-50d4bbc89e72 61 fields · synced Jul 10, 2026
- EUDAMED 7841eef2-070a-4f94-9901-6f2cc4dee310 61 fields · synced May 18, 2026