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I/A bimanual instrument set
EUDAMEDClass IIa (EU MDR)
Ref VE654103Model MD0105.113 I/A Instruments Reusable
Identity
- Trade Name
- I/A bimanual instrument set EUDAMED
- Model / Reference
- MD0105.113 I/A Instruments Reusable EUDAMEDVE654103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003909234 EUDAMED
- Basic UDI-DI
- 76300039MD0105113V4 EUDAMED
- Direct Marketing DI
- 07630003909234 EUDAMED
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
I/A bimanual instrument set by Oertli Instrumente Ag — Class IIa — 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 | 76300039MD0105113V4 | Class IIa | 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 43ad0ae1-7b25-42af-b6e4-c270c971e6ea 61 fields · synced Jun 18, 2026