← Back to catalogue
Celluma Series 2 RESTORE
EUDAMEDClass IIa (EU MDR)
Ref 850523007860Model Celluma Series 2 CONTOUR - EU
Identity
- Trade Name
- Celluma Series 2 RESTORE EUDAMED
- Model / Reference
- Celluma Series 2 CONTOUR - EU EUDAMED850523007860 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850523007860 EUDAMED
- Basic UDI-DI
- 0850523007Celluma6Q EUDAMED
- Direct Marketing DI
- 00850523007860 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 RESTORE by BioPhotas, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Red-light phototherapy unit, professional.
- Lumie Brazil — Outside In (Cambridge) Ltd trading as Lumie · Class IIa
- Controller Unit (CU+) — MEDI-TECH INTERNATIONAL CORPORATION · Class II
- PRO WELLNESS — PHOTON 4 HEALTH B.V. · Class I
- Shark cryoglow — SharkNinja Operating LLC · Class IIa
- Bodyclock Luxe 700FM — Outside In (Cambridge) Ltd trading as Lumie · Class I
- BASIC MIND WELLNESS SYSTEM® — PHOTON 4 HEALTH B.V. · Class I
- Ströme Energy+ — Zero-Plus International Limited · Class IIa
- HYDRO 4 HEALTH® LASER ATP WRISTBAND — PHOTON 4 HEALTH B.V. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioPhotas, Inc.
- EUDAMED SRN
- US-MF-000013481
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d7fe02a6-60eb-4191-a1e4-b5765229ca86 61 fields · synced Jun 20, 2026