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ProfiLine PLUS Pen-Nadel
EUDAMEDClass IIa (EU MDR)
Ref CIG-WELL128EOModel 8mm (30G) 100ct
Identity
- Trade Name
- ProfiLine PLUS Pen-Nadel EUDAMED
- Device Name
- ProfiLine PLUS Pen-Nadeln EUDAMED
- Model / Reference
- 8mm (30G) 100ct EUDAMEDCIG-WELL128EO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09010727011037 EUDAMED
- Basic UDI-DI
- B-09010727011037 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
ProfiLine PLUS Pen-Nadel 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-09010727011037 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MED TRUST Handelsges.m.b.H.
- EUDAMED SRN
- AT-MF-000000311
Sources (1)
- EUDAMED b111f6cd-c112-48ee-8c81-4665afcc512e 61 fields · synced Sep 30, 2026