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Medoject Fine
EUDAMEDClass IIa (EU MDR)
Ref 805.M3105.DS.VTModel MOWANARef 805.M3104.DS.VT
Identity
- Trade Name
- MEDOJECT FINE EUDAMED
- Device Name
- Hypodermic Pen Needles EUDAMED
- Model / Reference
- MOWANA EUDAMED805.M3105.DS.VT EUDAMED805.M3104.DS.VT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551014892071 EUDAMED09551014892064 EUDAMED
- Basic UDI-DI
- 955101489PENNEEDLEPS EUDAMED
- Direct Marketing DI
- 09551014892071 EUDAMED09551014892064 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medoject Fine by Pentamaster MediQ Sdn. Bhd. — 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 | 955101489PENNEEDLEPS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pentamaster MediQ Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000049132
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (2)
- EUDAMED cc4edd79-1d16-4073-9369-d718e0db0f62 61 fields · synced Jul 25, 2026
- EUDAMED c3b97bc8-94af-4a02-8914-531b5f7735dd 61 fields · synced May 19, 2026