Identity
- Trade Name
- Shark CryoGlow EUDAMED
- Device Name
- Shark CryoGlow EUDAMED
- Model / Reference
- CryoGlow EUDAMEDFW312IE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10622356345504 EUDAMED
- Basic UDI-DI
- 0622356FW300JA EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Red-light phototherapy unit, professional
Shark CryoGlow by SharkNinja Operating LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0622356FW300JA | Class IIa | Active |
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Manufacturer
- Manufacturer
- SharkNinja Operating LLC
- EUDAMED SRN
- US-MF-000048207
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6f7b837a-794f-4db8-bdae-42e4b3e274a1 61 fields · synced Jun 18, 2026