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Bracket Assy, Orascoptic ROH Elite/Ergo Edge
EUDAMEDClass I (EU MDR)
Ref 4708-0026-0000
Identity
- Trade Name
- Bracket Assy, Orascoptic ROH Elite/Ergo Edge EUDAMED
- Device Name
- Bracket Assy, Orascoptic ROH Elite/Ergo Edge EUDAMED
- Model / Reference
- 4708-0026-0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810070572280 EUDAMED
- Basic UDI-DI
- 081007057LED73TY EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Bracket Assy, Orascoptic ROH Elite/Ergo Edge by Designs for Vision, Inc. — 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 | 081007057LED73TY | Class I | Active |
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Manufacturer
- Manufacturer
- Designs for Vision, Inc.
- EUDAMED SRN
- US-MF-000013810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4b1bd435-dcd3-4c39-9266-bb82b306f47a 61 fields · synced Sep 17, 2026