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Cryogesic Direct Stream
EUDAMEDClass IIa (EU MDR)
Ref CRYOGESICDIR100ML
by Vitame Ltd
Identity
- Trade Name
- Cryogesic Direct Stream EUDAMED
- Device Name
- Cryogesic Fine Spray EUDAMEDCryogesic Direct Stream EUDAMED
- Model / Reference
- CRYOGESICDIR100ML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060411670068 EUDAMED
- Basic UDI-DI
- 506041167VAPOCOOLANTWE EUDAMEDB-05060411670068 EUDAMED
- Direct Marketing DI
- 05060411670068 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMEDNorthern 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Cryogesic Direct Stream by Vitame Ltd — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
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- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506041167VAPOCOOLANTWE | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506041167VAPOCOOLANTWE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vitame Ltd
- EUDAMED SRN
- GB-MF-000015647
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (2)
- EUDAMED a5916b51-4610-4bbb-aa80-eafd5281e8f4 61 fields · synced Jul 31, 2026
- EUDAMED 67c478a7-159b-4e1f-9d7a-b26fca77fa34 61 fields · synced May 19, 2026