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Intensive Care Phototherapy
EUDAMEDClass IIb (EU MDR)
Ref BC 350 000Model BC 350Ref BC 250 LCDRef BC 250 000Model BC 250Ref BC 050 000Model BC 050Ref BC 250 LED
Identity
- Trade Name
- Intensive Care Phototherapy EUDAMED
- Device Name
- Intensive Care Phototherapy EUDAMED
- Model / Reference
- BC 350 EUDAMEDBC 350 000 EUDAMEDBC 250 LCD EUDAMEDBC 250 EUDAMEDBC 250 000 EUDAMEDBC 050 EUDAMEDBC 050 000 EUDAMEDBC 250 LED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680992312545 EUDAMED08680992311128 EUDAMED08680992312064 EUDAMED08680992311234 EUDAMED08680992311258 EUDAMED08680052458886 EUDAMED08680992311111 EUDAMED08680992312101 EUDAMED08680992311296 EUDAMED08680992311241 EUDAMED08680992312118 EUDAMED
- Basic UDI-DI
- B-08680992312545 EUDAMEDB-08680992311128 EUDAMEDB-08680992312064 EUDAMEDB-08680992311234 EUDAMEDB-08680992311258 EUDAMEDB-08680052458886 EUDAMEDB-08680992311111 EUDAMEDB-08680992312101 EUDAMEDB-08680992311296 EUDAMEDB-08680992311241 EUDAMEDB-08680992312118 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Red-light phototherapy unit, professional
Intensive Care Phototherapy by Okuman Medikal Sistemler Anonim Sirketi — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08680992312545 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Okuman Medikal Sistemler Anonim Sirketi
- EUDAMED SRN
- TR-MF-000015167
Sources (11)
- EUDAMED dee0ecc7-9805-4cd0-8a19-2a310e668275 61 fields · synced Jul 30, 2026
- EUDAMED 8f20d1bb-026c-4418-8ec9-263e9811002f 61 fields · synced May 17, 2026
- EUDAMED b1870dbc-83fc-47ec-8f24-4899ebd48c64 61 fields · synced May 17, 2026
- EUDAMED 7aeda950-771a-43ab-89f8-a87c6837139b 61 fields · synced May 17, 2026
- EUDAMED 51e1b8c9-8f72-4bd9-8d7f-651c2e5edc95 61 fields · synced May 17, 2026
- EUDAMED 5dff4be9-6659-48d2-ab0f-890e05028c36 61 fields · synced May 17, 2026
- EUDAMED 88b577cf-2482-4f76-b3b5-7da61fc06424 61 fields · synced May 18, 2026
- EUDAMED 11fcbc61-9cfb-4551-a540-37397d6504ec 61 fields · synced May 18, 2026
- EUDAMED d843616e-e464-42d2-9339-e052707f6213 61 fields · synced May 18, 2026
- EUDAMED cd21459c-e861-4581-a166-6ce794a34a70 61 fields · synced May 19, 2026
- EUDAMED 8dbfe91d-5d0b-4513-9de9-a6ade9ed88b0 61 fields · synced May 19, 2026