Identity
- Trade Name
- Beurer EUDAMEDBeurer(IH55) EUDAMED
- Device Name
- infrared lamp EUDAMEDNebulizer EUDAMED
- Model / Reference
- SN-52A EUDAMEDIL50 EUDAMEDIH55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975383560509 EUDAMED06975383560202 EUDAMED
- Basic UDI-DI
- 697538356I02S4 EUDAMED697538356N01ST EUDAMED
- Direct Marketing DI
- 06975383560509 EUDAMED06975383560202 EUDAMED
- EMDN Code
- Z120614 INFRARED ULTRAVIOLET RAY LAMPS EUDAMEDR060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Beurer by Foshan Gaunying Electronics Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697538356I02S4 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foshan Gaunying Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000017213
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (3)
- EUDAMED 712076b2-07f7-4e1b-995f-81eea6730642 61 fields · synced Aug 3, 2026
- EUDAMED 30c1d922-c755-4229-8039-036644e6c904 61 fields · synced May 18, 2026
- EUDAMED 4b61e4e2-1d11-4beb-a449-6b602e4e9eb8 61 fields · synced Jun 19, 2026