Identity
- Trade Name
- medisana EUDAMED
- Device Name
- infrared lamp EUDAMEDIR-850 EUDAMED
- Model / Reference
- SN-52A EUDAMEDIR-850 EUDAMEDinfrared lamp EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975383560400 EUDAMED
- Basic UDI-DI
- 697538356I02S4 EUDAMEDB-06975383560400 EUDAMED
- Direct Marketing DI
- 06975383560400 EUDAMED
- EMDN Code
- Z120614 INFRARED ULTRAVIOLET RAY LAMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
medisana by Foshan Gaunying Electronics Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697538356I02S4 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697538356I02S4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Gaunying Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000017213
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED f3155c3a-f960-44e7-85b2-9782776600e3 61 fields · synced Jul 24, 2026
- EUDAMED f9aca43e-9101-4b14-893c-3cdf24b33516 61 fields · synced May 19, 2026