Identity
- Trade Name
- Exhaust Collection Bag EUDAMEDFDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, electronic FDA UDI
- Device Name
- Exhaust Collection Bag EUDAMEDExhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device FDA UDI
- Model / Reference
- FGS-7015 EUDAMEDFDA UDI
- Description
- Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008595042 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850008595ECBZF EUDAMED
- PMA Number
- P180032 FDA UDI
- FDA Product Code
- MNB FDA UDI
- EMDN Code
- Z12080201 ENDOMETRIAL ABLATION EQUIPMENT EUDAMED
- GMDN Term
- General cryosurgical system, cryogen gas, electronic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
Exhaust Collection Bag by Channel Medsystems, Inc. — Class I — 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 | 0850008595ECBZF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Channel Medsystems, Inc.
- EUDAMED SRN
- US-MF-000028229
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 5bca8d32-6ae9-43ca-a159-45e74ef5c3b1 61 fields · synced Jun 18, 2026
- FDA UDI c80d6745-a773-4ffc-ba44-eb8a6c636029 36 fields · synced May 30, 2026