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Orbis Bio-Based Barrier envelopes, size 3
EUDAMEDClass I (EU MDR)
Ref R201435
by Berner Oy
Identity
- Trade Name
- Orbis Bio-Based Barrier envelopes, size 3 EUDAMED
- Device Name
- Disposable cover for dental x-ray device EUDAMED
- Model / Reference
- R201435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06414505187502 EUDAMED
- Basic UDI-DI
- 6414505SPT8 EUDAMED
- Direct Marketing DI
- 06414505187502 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 Bio-Based Barrier envelopes, size 3 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 8070a1be-ae23-4a17-8c0f-a4d7a45832b5 61 fields · synced Jul 17, 2026