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I/A bimanual instrument set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VE654101Model MD0105.113 I/A Instruments Reusable
Identity
- Trade Name
- I/A bimanual instrument set EUDAMEDOertli® FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- I/A BIMANUELL INSTRUMENTEN-SET; I/A BIMANUAL INSTRUMENT KIT; JEU D'INSTRUMENTS BIMANUELS FDA UDI
- Model / Reference
- MD0105.113 I/A Instruments Reusable EUDAMEDVE654101 EUDAMEDFDA UDI
- Description
- I/A BIMANUELL INSTRUMENTEN-SET; I/A BIMANUAL INSTRUMENT KIT; JEU D'INSTRUMENTS BIMANUELS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003900958 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD0105113V4 EUDAMED
- Direct Marketing DI
- 07630003900958 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
I/A bimanual instrument set by Oertli Instrumente Ag — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300039MD0105113V4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (2)
- EUDAMED be07263f-bdb9-4ed7-8bf7-dec4884832f0 61 fields · synced Jul 16, 2026
- FDA UDI 2a78998e-5569-4dcd-b186-17e88b9e062d 34 fields · synced May 30, 2026