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Unistik 3 Normal (23G 1.8mm)
EUDAMEDClass IIa (EU MDR)
Ref AT1002Ref AT1008Ref AT1004Ref 001197
Identity
- Trade Name
- Unistik 3 Normal (23G 1.8mm) EUDAMED
- Device Name
- Unistik 3 EUDAMED
- Model / Reference
- AT1002 EUDAMEDAT1008 EUDAMEDAT1004 EUDAMED001197 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189100214 EUDAMED05016189100818 EUDAMED05016189100412 EUDAMED05016189119711 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 Normal (23G 1.8mm) 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 (4)
- EUDAMED 8e5b5989-a769-480c-9868-dccce631ba31 61 fields · synced Jul 21, 2026
- EUDAMED fd188281-7e74-4637-8923-8bf30f0f5519 61 fields · synced May 16, 2026
- EUDAMED 63c99d61-50f3-432b-ac78-b85dc9da1406 61 fields · synced May 16, 2026
- EUDAMED d2db89fd-f917-4aea-a81f-e2f79151294a 61 fields · synced May 18, 2026