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exciplex
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref EIPL-PRD-K01Model EIPL-100510(k) K191086Ref EIPL-PRD-K01-8
by Clarteis Sas
Identity
- Trade Name
- exciplex EUDAMED
- Device Name
- exciplex EUDAMED
- Model / Reference
- EIPL-100 EUDAMEDEIPL-PRD-K01 EUDAMEDEIPL-PRD-K01-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EIPL-100FH EUDAMED03760313460072 EUDAMED
- Basic UDI-DI
- B-EIPL-100FH EUDAMED376031346EIPL-100DB EUDAMED
- Direct Marketing DI
- 03760313460072 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDItaly 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
exciplex by Clarteis Sas — Class IIb — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-EIPL-100FH | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K191086 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-EIPL-100FH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Clarteis Sas
- EUDAMED SRN
- FR-MF-000002542
- FDA Applicant
- Clarteis
Sources (3)
- EUDAMED e6c9fe14-8b8d-4dd1-9494-ada0b1fb8f4e 85 fields · synced Jul 17, 2026
- EUDAMED f28ab5c2-eedf-4258-8ffc-10af3f122e49 61 fields · synced Jul 17, 2026
- FDA 510(k) K191086 1 fields · synced May 18, 2026