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Unistik Touch Opaque (30G 1.5mm)
EUDAMEDClass IIa (EU MDR)
Ref 000711Ref 000710
Identity
- Trade Name
- Unistik Touch Opaque (30G 1.5mm) EUDAMED
- Device Name
- Unistik Touch EUDAMED
- Model / Reference
- 000711 EUDAMED000710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189171115 EUDAMED05016189171016 EUDAMED
- Basic UDI-DI
- 5016189UNISTIKTOUCHKF 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
Unistik Touch Opaque (30G 1.5mm) 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 | 5016189UNISTIKTOUCHKF | 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 4ec4951b-d84a-472a-a050-3fa2f8a1ab72 61 fields · synced Jul 15, 2026
- EUDAMED c40dbaaa-001e-4977-bfe0-f8141949c2d0 61 fields · synced May 19, 2026