Identity
- Trade Name
- HR1121 EUDAMED
- Model / Reference
- HR Head Rests EUDAMEDHR1121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430021931825 EUDAMED
- Basic UDI-DI
- 643002193OTA0005YA EUDAMED
- Direct Marketing DI
- 06430021931825 EUDAMED
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Hr1121 by Lojer Oy — 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 | 643002193OTA0005YA | Class I | Active |
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Manufacturer
- Manufacturer
- Lojer Oy
- EUDAMED SRN
- FI-MF-000001639
Sources (1)
- EUDAMED f5cdadce-e6c4-4e82-af66-5eb2cdd498c8 61 fields · synced Jun 18, 2026