Identity
- Trade Name
- Baybio EUDAMED
- Device Name
- Nucleic Acid Extraction and Purification Reagents EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975938850000 EUDAMED
- Basic UDI-DI
- 697593885NAEAPRZ8 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Category: Nucleic acid extraction/isolation kit IVD
Baybio by Guangzhou Baybio Bio-Tech Co., Ltd — 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 | 697593885NAEAPRZ8 | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Baybio Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000030650
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 31028cb3-7d93-47f5-a1fb-a3624678f56b 61 fields · synced Jun 18, 2026