Identity
- Trade Name
- Gavlar OPAL 3-60, 90cm EUDAMED
- Model / Reference
- Gavlar 3-60 EUDAMED455090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350005893019 EUDAMED
- Basic UDI-DI
- 735000589GAV360Z6 EUDAMED
- Direct Marketing DI
- 07350005893019 EUDAMED
- EMDN Code
- V08068001 BED RAILS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Gavlar OPAL 3-60, 90cm by ComfortSystem Scandinavia AB — 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 | 735000589GAV360Z6 | Class I | Active |
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Manufacturer
- Manufacturer
- ComfortSystem Scandinavia AB
- EUDAMED SRN
- SE-MF-000038482
Sources (1)
- EUDAMED 4eb4da8c-fbfe-447d-be59-847592b29a1c 61 fields · synced Aug 1, 2026