Identity
- Trade Name
- 7109 EUDAMED
- Device Name
- Slide EUDAMED
- Model / Reference
- many EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979040058194 EUDAMED
- Basic UDI-DI
- 697904005SLIDENC EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen microscopy slide IVD, single-use
7109 by Haimen Henghui Lab Equipment Manufacturing Factory — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697904005SLIDENC | Class A | Active |
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Manufacturer
- Manufacturer
- Haimen Henghui Lab Equipment Manufacturing Factory
- EUDAMED SRN
- CN-MF-000048920
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED a0e70732-56a8-41d6-a018-4fdb1e6b8ca5 61 fields · synced Jun 19, 2026