Identity
- Trade Name
- FBB Gen 1.0 EUDAMED
- Device Name
- Phlecs full body blue EUDAMED
- Model / Reference
- FBB-Gen1.0 EUDAMED1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FBB-GEN1.0LL EUDAMED
- Basic UDI-DI
- B-FBB-GEN1.0LL EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Red-light phototherapy unit, professional
FBB Gen 1.0 by Phlecs B.V. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Red-light phototherapy unit, professional.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-FBB-GEN1.0LL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Phlecs B.V.
- EUDAMED SRN
- NL-MF-000003903
Sources (1)
- EUDAMED b25fbda2-30a6-4f8f-9849-1fdf3b8c1f24 61 fields · synced Jun 17, 2026