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CryoTreQ
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref CT00.D01510(k) K202038
by VitreQ B.V.
Identity
- Trade Name
- VitreQ FDA UDI
- Generic Name
- Ophthalmic cryosurgical system, mechanical FDA UDI
- Device Name
- CryoTreQ EUDAMEDFDA UDI
- Model / Reference
- CT00.D01 EUDAMEDFDA UDI
- Description
- CryoTreQ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719214223458 EUDAMED88719214223454 FDA UDI
- Basic UDI-DI
- 871921422981GF EUDAMED
- Unit of Use DI
- 88719214223454 EUDAMED
- 510(k) Number
- K202038 FDA UDI
- FDA Product Code
- HPS FDA UDI
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
- GMDN Term
- Ophthalmic cryosurgical system, mechanical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4170 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
CryoTreQ by Vitreq B.V. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202038 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 871921422981GF | Class IIa | Active |
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Manufacturer
- Manufacturer
- VitreQ B.V.
- EUDAMED SRN
- NL-MF-000000424
- FDA Applicant
- VitreQ BV
Sources (4)
- EUDAMED 8c2b5f3a-c758-467b-af2c-2317c5781805 85 fields · synced Jul 15, 2026
- FDA UDI b108f60c-92cc-4f97-8227-60e7f961c16b 35 fields · synced May 30, 2026
- EUDAMED ba73eee7-5fb4-4b4a-bf88-c260beb9a6cf 61 fields · synced Jul 15, 2026
- FDA 510(k) K202038 1 fields · synced May 18, 2026