Identity
- Trade Name
- Helmet for resi PRONE EUDAMED
- Device Name
- resi PRONE Helmet EUDAMED
- Model / Reference
- PFHT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640372030255 EUDAMED
- Basic UDI-DI
- 764037203PFHT&PFMR83 EUDAMED
- Direct Marketing DI
- 07640372030255 EUDAMED
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES 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
Helmet for resi PRONE by Anel AG — 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 | 764037203PFHT&PFMR83 | Class I | Active |
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Manufacturer
- Manufacturer
- Anel AG
- EUDAMED SRN
- CH-MF-000033240
- Authorised Representative
- Basmed GmbH DE-AR-000049709
Sources (1)
- EUDAMED d61ecfd7-63b2-4473-b83e-9cce8d2538c2 61 fields · synced Jul 28, 2026