Identity
- Trade Name
- Auto Sampling Instrument EUDAMED
- Device Name
- Auto Sampling Instrument EUDAMED
- Model / Reference
- SCAN-10 EUDAMED1312002005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025210382 EUDAMED
- Basic UDI-DI
- 69710252103371024002EJ EUDAMED
- Direct Marketing DI
- 06971025210382 EUDAMED
- EMDN Code
- W02039099 VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania 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
Auto Sampling Instrument by Zhuhai DL Biotech Co., Ltd. — 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 | 69710252103371024002EJ | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai DL Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000036485
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 7fbe27e9-3272-4436-8a38-ca9cd68fbe5d 61 fields · synced Jun 19, 2026