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Dual-linear, wireless pedal for OS 4
EUDAMEDClass IIb (EU MDR)
Ref VE860010Model MD1105.08 OS4 Ophthalmic Surgery System
Identity
- Trade Name
- Dual-linear, wireless pedal for OS 4 EUDAMED
- Model / Reference
- MD1105.08 OS4 Ophthalmic Surgery System EUDAMEDVE860010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003911602 EUDAMED
- Basic UDI-DI
- 76300039MD110508TR EUDAMED
- Direct Marketing DI
- 07630003911602 EUDAMED
- EMDN Code
- Q020499,Q020699 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Dual-linear, wireless pedal for OS 4 by Oertli Instrumente Ag — Class IIb — 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 | 76300039MD110508TR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (1)
- EUDAMED fa882761-c977-43af-a691-5fc4166a0083 61 fields · synced Jun 18, 2026