Identity
- Trade Name
- Cryo Professional FDA UDI
- Generic Name
- Cryogenic spray, cutaneous FDA UDI
- Device Name
- Cryo Professional Applicator (30x2mm, 30x5mm) FDA UDI
- Model / Reference
- UTM0400 FDA UDI
- Description
- Cryo Professional Applicator (30x2mm, 30x5mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717484792834 FDA UDI
- 510(k) Number
- K152203 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Cryogenic spray, cutaneous FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Cryogenic spray, cutaneous
Cryo Professional by Koninklijke Utermöhlen N.V. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cryogenic spray, cutaneous.
- CryoLab Medical — CRYOCONCEPTS, LP · Class II
- CryOmega — CRYOCONCEPTS, LP · Class II
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- CryoClear — CRYOCONCEPTS, LP · Class II
- Premier CryOmega — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY · Class II
- CryoLab Aesthetics — CRYOCONCEPTS, LP · Class II
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY · Class II
Cleared under the same submission
K152203 also covers:
- ICEOUT™ — BOVIE MEDICAL CORPORATION
- ICEOUT™ — BOVIE MEDICAL CORPORATION
- ICEOUT™ — BOVIE MEDICAL CORPORATION
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
- Cryo Professional — Koninklijke Utermöhlen N.V.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koninklijke Utermöhlen N.V.
Sources (2)
- FDA UDI 379b364a-08c9-4266-9c1f-6a9a1b12ea0d 36 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026