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cryoICE® System
EUDAMEDClass I (EU MDR)
Ref A001150-13Model A001150 ACM Exhaust Hose Connector
Identity
- Trade Name
- cryoICE® System EUDAMED
- Device Name
- ACM Exhaust Hose Connector EUDAMED
- Model / Reference
- A001150 ACM Exhaust Hose Connector EUDAMEDA001150-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840143905216 EUDAMED
- Basic UDI-DI
- 08401439000000000000005ZK EUDAMED
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
cryoICE® System by Atricure, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08401439000000000000005ZK | Class I | Active |
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Manufacturer
- Manufacturer
- AtriCure, Inc.
- EUDAMED SRN
- US-MF-000002974
- Authorised Representative
- AtriCure Europe B.V. NL-AR-000000165
Sources (1)
- EUDAMED 6083cc66-4650-47ac-b2b2-42c1e80670e3 61 fields · synced May 23, 2026