Cry-Baby
by Brymill Cryogenic Systems United States EUDAMEDGUDID
Ref B-400Model B-400, CRY-BABY
Product code GEHEMDN V0902
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00817434020012 | Date22 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00817434020012 | Date18 Oct 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- General cryosurgical system, cryogen gas, mechanical
- Model / Ref / Catalog
- B-400, CRY-BABY
- Primary DI / UDI-DI
- 00817434020012
- Basic UDI-DI
- B-00817434020012
- FDA Product Code
- GEH
- EMDN Code
- V0902 Clinical/therapeutic applications liquid nitrogen
- GMDN Term
- General cryosurgical system, cryogen gas, mechanical
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 878.4350
- Market of Registration
- Spain
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000031796
- Authorised representative
- ROSA MARIA SALLENT MOYA ES-AR-000030788
Other devices from Brymill Cryogenic Systems
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 588131fd-6d19-43cb-8eda-da0988708df3
- FDA UDI 5be8c35f-4e7c-4fa4-a29d-20116619f625