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Orbis Hygienic protective covers for OPG bite blocks
EUDAMEDClass I (EU MDR)
Ref R201442
by Berner Oy
Identity
- Trade Name
- Orbis Hygienic protective covers for OPG bite blocks EUDAMED
- Device Name
- Disposable cover for dental x-ray device EUDAMED
- Model / Reference
- R201442 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06414505183252 EUDAMED
- Basic UDI-DI
- 6414505SPT8 EUDAMED
- Direct Marketing DI
- 06414505183252 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER 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
Orbis Hygienic protective covers for OPG bite blocks by Berner 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 | 6414505SPT8 | Class I | Active |
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Manufacturer
- Manufacturer
- Berner Oy
- EUDAMED SRN
- FI-MF-000007402
Sources (1)
- EUDAMED 24655f7e-e7fe-4dab-bc3c-d7328ab42956 61 fields · synced Aug 2, 2026