Identity
- Trade Name
- S-Chip EUDAMED
- Device Name
- S-Chip EUDAMED
- Model / Reference
- S-Chip EUDAMEDDCS-S01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317541150 EUDAMED
- Basic UDI-DI
- 880931754S-ChipPM EUDAMED
- EMDN Code
- W050301029099 SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
New Device
No
EUDAMED
S-Chip by NanoEnTek, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 880931754S-ChipPM | Class A | Active |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED aa431a7b-1dba-44b0-a340-626d211ecbcd 61 fields · synced Jul 18, 2026