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Wellion PROTECT PRO SAFETY PENNEEDLES
EUDAMEDClass IIa (EU MDR)
Ref WELL128RModel 8mm, 30GRef WELL126RModel 6mm, 30GRef WELL125RModel 5mm, 30G
Identity
- Trade Name
- Wellion PROTECT PRO SAFETY PENNEEDLES EUDAMED
- Device Name
- Wellion PROTECT PRO SAFETY PENNEEDLES EUDAMED
- Model / Reference
- 8mm, 30G EUDAMEDWELL128R EUDAMED6mm, 30G EUDAMEDWELL126R EUDAMED5mm, 30G EUDAMEDWELL125R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09010727000543 EUDAMED09010727000536 EUDAMED09010727000512 EUDAMED
- Basic UDI-DI
- B-09010727000543 EUDAMEDB-09010727000536 EUDAMEDB-09010727000512 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wellion PROTECT PRO SAFETY PENNEEDLES by MED TRUST Handelsges.m.b.H. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09010727000543 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MED TRUST Handelsges.m.b.H.
- EUDAMED SRN
- AT-MF-000000311
Sources (6)
- EUDAMED 506266f9-21b8-4b90-a691-06683ba6a5b1 61 fields · synced Jul 28, 2026
- EUDAMED a76a6562-a0a5-4a5d-af54-46fedccf47e8 61 fields · synced May 18, 2026
- EUDAMED 04d10459-95d8-47c3-a1cb-fa00e12931d5 61 fields · synced May 18, 2026
- EUDAMED 021ef939-20e4-42ce-8787-5af2118d5cb2 61 fields · synced Jun 19, 2026
- EUDAMED cdcd52c1-02ca-40f7-bca8-486e5a005be9 61 fields · synced Jul 13, 2026
- EUDAMED 7aab1ab8-0268-4593-ae33-fc1cf367ec60 61 fields · synced Jul 28, 2026