Identity
- Trade Name
- Head Immobilizers EUDAMED
- Device Name
- Head Immobilizers EUDAMED
- Model / Reference
- IMMO400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975293690174 EUDAMED
- Basic UDI-DI
- 697529369IMMO200AGM EUDAMED
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Head Immobilizers by Medsource Factory, Inc. — 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 | 697529369IMMO200AGM | Class I | Active |
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Manufacturer
- Manufacturer
- Medsource Factory, Inc.
- EUDAMED SRN
- CN-MF-000047853
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 127d6c9c-25c7-4a4d-8d64-93ac078ae645 61 fields · synced Jun 18, 2026