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Continuous Flow Cutter 25G
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VV105110Model MD0105.42 Vitrectomy Cutter Single Use
Identity
- Trade Name
- Continuous Flow Cutter 25G EUDAMEDOertli® FDA UDI
- Generic Name
- Vitrectomy system micro-cutting unit FDA UDI
- Device Name
- CONTINUOUS FLOW-CUTTER,; TWINAC, 25G; FDA UDI
- Model / Reference
- MD0105.42 Vitrectomy Cutter Single Use EUDAMEDVV105110 EUDAMEDFDA UDI
- Description
- CONTINUOUS FLOW-CUTTER,; TWINAC, 25G; FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003912340 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD010542TC EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020499 VITRECTOMY DEVICES - OTHER EUDAMED
- GMDN Term
- Vitrectomy system micro-cutting unit 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
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDI
Continuous Flow Cutter 25G 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 | 76300039MD010542TC | 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 936e9b66-acf9-4afb-a773-279388147144 61 fields · synced Jun 19, 2026
- FDA UDI c2618248-e890-42a9-9378-b2a0881305e1 35 fields · synced May 30, 2026