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Autoject 2. Fixed needle standard
EUDAMEDClass IIa (EU MDR)
Ref AJ1300EA000Model P003071A1*
Identity
- Trade Name
- Autoject 2. Fixed needle standard EUDAMED
- Device Name
- Autoject 2 EUDAMED
- Model / Reference
- P003071A1* EUDAMEDAJ1300EA000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189130013 EUDAMED
- Basic UDI-DI
- 5016189AUTOJECT2JS EUDAMED
- EMDN Code
- A018006 HYPODERMIC NEEDLES PEN INJECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Autoject 2. Fixed needle standard by Owen Mumford Ltd — 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 | 5016189AUTOJECT2JS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Owen Mumford Ltd
- EUDAMED SRN
- GB-MF-000021000
- Authorised Representative
- Owen Mumford GmbH DE-AR-000020700
Sources (1)
- EUDAMED d20a6920-a0ab-4c4b-89c3-c25d81405207 61 fields · synced Jun 19, 2026