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Therapeutical Laser Unit
EUDAMEDClass IIb (EU MDR)
Ref Hilthera 4.0
by REV-MED Inc.
Identity
- Device Name
- Therapeutical Laser Unit EUDAMED
- Model / Reference
- Hilthera 4.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809326582113 EUDAMED
- Basic UDI-DI
- B-08809326582113 EUDAMED
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden 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
Therapeutical Laser Unit by REV-MED Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08809326582113 | Class IIb | Active |
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Manufacturer
- Manufacturer
- REV-MED Inc.
- EUDAMED SRN
- KR-MF-000026506
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 4ba9e660-17c7-4070-9b43-7eceaa7d8aed 61 fields · synced Jun 18, 2026