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OIVS2Z Inverter Vitrectomy System For Zeiss Type Microscopes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 11159
Identity
- Trade Name
- OIVS2Z Inverter Vitrectomy System For Zeiss Type Microscopes EUDAMEDInverter Vitrectomy System For Zeiss Type Microscopes FDA UDI
- Generic Name
- Vitrectomy contact lens, reusable FDA UDI
- Device Name
- Contact Ophthalmic EUDAMED
- Model / Reference
- 11159 EUDAMEDOIVS2Z FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238111591 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262637 EUDAMED
- FDA Product Code
- HRM FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Vitrectomy contact lens, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
OIVS2Z Inverter Vitrectomy System For Zeiss Type Microscopes by Ocular Instruments, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 06302381262637 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ocular Instruments Inc.
- EUDAMED SRN
- US-MF-000007216
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9c83eebb-6b5e-48d4-b39a-aff02b6ed7c6 61 fields · synced Jun 18, 2026
- FDA UDI 4f664ed4-6db2-459d-ad24-ef787ec64f1b 32 fields · synced May 30, 2026