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I/A bimanual instrument set 0.8 MM
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VV650010Model MD0105.31 I/A Instruments Single Use
Identity
- Trade Name
- I/A bimanual instrument set 0.8 MM EUDAMEDOertli® FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- I/A BIMANUELL SET STERIL; I/A BIMANUAL SET STERILE; SET I/A BIMANUEL STERILE FDA UDI
- Model / Reference
- MD0105.31 I/A Instruments Single Use EUDAMEDVV650010 EUDAMEDFDA UDI
- Description
- I/A BIMANUELL SET STERIL; I/A BIMANUAL SET STERILE; SET I/A BIMANUEL STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003904789 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD010531T7 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
I/A bimanual instrument set 0.8 MM 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 | 76300039MD010531T7 | 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 84c1bc87-45ec-4343-b0ca-02ab1f4f9b06 61 fields · synced Jun 18, 2026
- FDA UDI eafffce2-ee86-47b8-97cd-471a69aa51a4 34 fields · synced May 30, 2026