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Mowana Auto Duo
EUDAMEDClass IIa (EU MDR)
Ref 805.M3104.DSModel MOWANARef 805.M3105.DSRef 805.M3108.DS
Identity
- Trade Name
- MOWANA AUTO DUO EUDAMED
- Device Name
- Hypodermic Pen Needles EUDAMED
- Model / Reference
- MOWANA EUDAMED805.M3104.DS EUDAMED805.M3105.DS EUDAMED805.M3108.DS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551014891326 EUDAMED09551014891333 EUDAMED09551014891319 EUDAMED
- Basic UDI-DI
- 955101489PENNEEDLEPS EUDAMED
- Direct Marketing DI
- 09551014891326 EUDAMED09551014891333 EUDAMED09551014891319 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
Mowana Auto Duo 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 (3)
- EUDAMED 5868ece4-ed04-4374-9443-6e2c59b213e9 61 fields · synced Jul 18, 2026
- EUDAMED 396114ea-edda-4b5c-8987-2add145bae00 61 fields · synced May 17, 2026
- EUDAMED f758e31d-5e67-45e7-b68c-7bd9e8065b2b 61 fields · synced May 18, 2026