Identity
- Device Name
- Process Record Slide EUDAMED
- Model / Reference
- Essential ver. 1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976270020011 EUDAMED
- Basic UDI-DI
- 697627002ESS1LM EUDAMED
- Unit of Use DI
- 06976270020014 EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Process Record Slide by ShenZhen PRS Limited. — 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 | 697627002ESS1LM | Class A | Active |
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Manufacturer
- Manufacturer
- ShenZhen PRS Limited.
- EUDAMED SRN
- CN-MF-000030723
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 3f3d67d8-8abd-4702-8e71-2c0bf6133149 61 fields · synced Jul 29, 2026