Identity
- Trade Name
- Wellion SAFETYLANCETS Blade EUDAMED
- Device Name
- Wellion SAFETYLANCETS EUDAMED
- Model / Reference
- WELL221B-1,8R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09010727000598 EUDAMED
- Basic UDI-DI
- 90107270006KY EUDAMED
- Unit of Use DI
- 09010727001861 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE 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
Category: Blood lancet, single-use
Wellion SAFETYLANCETS Blade by MED TRUST Handelsges.m.b.H. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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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 | 90107270006KY | Class IIa | Active |
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Manufacturer
- Manufacturer
- MED TRUST Handelsges.m.b.H.
- EUDAMED SRN
- AT-MF-000000311
Sources (2)
- EUDAMED d60ed025-24de-4263-a95d-57656b59a5c2-1 61 fields · synced Aug 1, 2026
- EUDAMED d60ed025-24de-4263-a95d-57656b59a5c2-2 61 fields · synced Aug 1, 2026