Identity
- Trade Name
- Gazelle PS EUDAMED
- Model / Reference
- Standing EUDAMED88010-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05707292524171 EUDAMED
- Basic UDI-DI
- 57072920536033A EUDAMED
- EMDN Code
- Y050202 STANDING FRAMES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Gazelle PS by R82 A/S — 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 | 57072920536033A | Class I | Active |
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Manufacturer
- Manufacturer
- R82 A/S
- EUDAMED SRN
- DK-MF-000000772
Sources (1)
- EUDAMED 7b9f9cea-a677-4d30-b325-8adf84cc69d6 61 fields · synced Jul 12, 2026