Identity
- Trade Name
- CryoPro Maxi EUDAMEDFDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- CryoPro Maxi EUDAMEDCryosurgical device with accessories FDA UDI
- Model / Reference
- E0200119 EUDAMED19 FDA UDI
- Description
- Cryosurgical device with accessories FDA UDI
Identifiers
- Catalog Number
- E0200119 FDA UDI
- Primary DI / UDI-DI
- 05710188020015 EUDAMEDFDA UDI
- Basic UDI-DI
- 5710188020018E EUDAMED
- Direct Marketing DI
- 05710188020015 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 Maxi 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 | 5710188020018E | 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 e8de0750-f40d-435e-ab4b-5afb9585e8c5 61 fields · synced May 30, 2026
- FDA UDI d944a6c2-3b47-4505-802f-5285b9585f98 36 fields · synced May 30, 2026