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Celluma Series 2 ELITE
EUDAMEDClass IIa (EU MDR)
Ref 850523007822Model Celluma Series 2 CONTOUR - EU
Identity
- Trade Name
- Celluma Series 2 ELITE EUDAMED
- Model / Reference
- Celluma Series 2 CONTOUR - EU EUDAMED850523007822 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850523007822 EUDAMED
- Basic UDI-DI
- 0850523007Celluma6Q EUDAMED
- Direct Marketing DI
- 00850523007822 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Celluma Series 2 ELITE by BioPhotas, Inc. — 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 | 0850523007Celluma6Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- BioPhotas, Inc.
- EUDAMED SRN
- US-MF-000013481
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 855866f9-7cbd-4646-acc8-f2a640b6edb3 61 fields · synced Jul 15, 2026