Identity
- Trade Name
- CryoPro Mini EUDAMEDFDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- CryoPro Mini EUDAMEDCryosurgical equipment with accessories FDA UDI
- Model / Reference
- E0200219 EUDAMED19 FDA UDI
- Description
- Cryosurgical equipment with accessories FDA UDI
Identifiers
- Catalog Number
- E0200219 FDA UDI
- Primary DI / UDI-DI
- 05710188020022 EUDAMEDFDA UDI
- Basic UDI-DI
- 5710188020028G EUDAMED
- Direct Marketing DI
- 05710188020022 EUDAMED
- 510(k) Number
- K982280 FDA UDI
- FDA Product Code
- GEH FDA UDI
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
- GMDN Term
- General cryosurgical system, cryogen gas, mechanical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CryoPro Mini by Cortex Technology Aps — 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 | 5710188020028G | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cortex Technology Aps
- EUDAMED SRN
- DK-MF-000002984
Sources (2)
- EUDAMED 44f83bad-e5c0-4229-8cb6-f6c02dea4248 61 fields · synced Aug 2, 2026
- FDA UDI 3b6de475-0626-43b3-8d3b-a542da493908 36 fields · synced May 30, 2026