← Back to catalogue
Test chamber for phaco
EUDAMEDFDA UDIClass I (EU MDR)
Ref VV803100Model MD0105.125 Test Chamber Reusable
Identity
- Trade Name
- Test chamber for phaco EUDAMEDOertli® FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, reusable FDA UDI
- Device Name
- TESTKAMMER FÜR PHAKO; TEST CHAMBER FOR PHACO; CHAMBRE TEST PHACO FDA UDI
- Model / Reference
- MD0105.125 Test Chamber Reusable EUDAMEDVV803100 EUDAMEDFDA UDI
- Description
- TESTKAMMER FÜR PHAKO; TEST CHAMBER FOR PHACO; CHAMBRE TEST PHACO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003905533 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD0105125VB EUDAMED
- Direct Marketing DI
- 07630003905533 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Z1212020799 PHACO-VITRECTOMY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Phacoemulsification system handpiece tip, reusable FDA UDI
Classification
- Device Class
- Class I 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
Test chamber for phaco by Oertli Instrumente Ag — Class I — 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 | 76300039MD0105125VB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (2)
- EUDAMED 9f1db395-f587-4575-bb03-baad17aff15a 61 fields · synced Jun 19, 2026
- FDA UDI f8acddb0-36ae-430f-81e2-d1f793fbf60e 34 fields · synced May 26, 2026