Identity
- Trade Name
- Aerobic blood culture bottle EUDAMED
- Device Name
- Aerobic blood culture bottle EUDAMED
- Model / Reference
- I-1 EUDAMED2610001011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025210054 EUDAMED
- Basic UDI-DI
- 69710252100541010001A7 EUDAMED
- Direct Marketing DI
- 06971025210054 EUDAMED
- EMDN Code
- W0104010504 BOTTLES FOR AUTOMATED BLOOD CULTURE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Aerobic blood culture bottle 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 | 69710252100541010001A7 | 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 8c9e084c-8287-493a-9a35-028569041dcd 61 fields · synced Jul 26, 2026