Identity
- Trade Name
- VitreQ FDA UDI
- Generic Name
- Ophthalmic surgical instrument handle, manual FDA UDI
- Device Name
- Cleaning Adaptor EUDAMEDFDA UDI
- Model / Reference
- FC00.R03 EUDAMEDFDA UDI
- Description
- Cleaning Adaptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719214221782 EUDAMEDFDA UDI
- Basic UDI-DI
- 871921422984GM EUDAMED
- Direct Marketing DI
- 18719214221789 EUDAMED
- FDA Product Code
- HNR FDA UDI
- EMDN Code
- L01040504 VITREO-RETINA SURGERY SCISSORS, REUSABLE EUDAMED
- GMDN Term
- Ophthalmic surgical instrument handle, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Cleaning Adaptor by Vitreq B.V. — 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 | 871921422984GM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VitreQ B.V.
- EUDAMED SRN
- NL-MF-000000424
Sources (2)
- EUDAMED 52c4fe6a-0452-45bb-bcf3-4f874f8b5f7e 61 fields · synced Jun 18, 2026
- FDA UDI 38486ce5-669f-4033-806c-e08c76110b12 34 fields · synced May 30, 2026