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305001
EUDAMEDClass I (EU MDR)
Ref 305001Model Head, Neck, and Shoulder Devices
by Medtec LLC
Identity
- Model / Reference
- Head, Neck, and Shoulder Devices EUDAMED305001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841439114100 EUDAMED
- Basic UDI-DI
- 8414391OC0005R01AQ EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
305001 by Medtec LLC — Class I — 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 | 8414391OC0005R01AQ | Class I | Active |
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Manufacturer
- Manufacturer
- Medtec LLC
- EUDAMED SRN
- US-MF-000002608
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 5c6a6318-75c7-4974-82ff-c6cea707fe17 61 fields · synced Jul 16, 2026