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CryOmega
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 160-2004Model CryOmega International - Twin Pack510(k) K172769
Identity
- Trade Name
- CryOmega EUDAMED
- Device Name
- CryOmega II EUDAMED
- Model / Reference
- CryOmega International - Twin Pack EUDAMED160-2004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850077006463 EUDAMED
- Basic UDI-DI
- B-00850077006463 EUDAMED
- 510(k) Number
- K172769 FDA 510(k)
- FDA Product Code
- GEH FDA 510(k)
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4350 FDA 510(k)
- Regulation Number
- 878.4350 FDA 510(k)
- Market of Registration
- Czechia EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CryOmega by Cryoconcepts, Lp — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172769 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00850077006463 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CryoConcepts, LP
- EUDAMED SRN
- US-MF-000009822
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ac578454-3bb5-4e85-8e2e-1c191f4e3b4c 61 fields · synced Jul 26, 2026
- FDA 510(k) K172769 24 fields · synced May 18, 2026