Identity
- Trade Name
- OOK SNOW, OOK SNOW MH EUDAMED
- Device Name
- OOK SNOW; OOK SNOW MH EUDAMED
- Model / Reference
- FL36-SC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00670482000678 EUDAMED
- Basic UDI-DI
- 67048200067PT EUDAMED
- EMDN Code
- V08060105,V08060199,V08068099 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ook Snow, Ook Snow Mh by Umano Medical 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 | 67048200067PT | Class I | Active |
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Manufacturer
- Manufacturer
- Umano Medical Inc.
- EUDAMED SRN
- CA-MF-000015592
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ef0dd1a8-99d8-4529-bd95-0ffcbda0865f 61 fields · synced Oct 6, 2026