← Back to catalogue
Blood Culture Positive Sample Pretreatment Kit
EUDAMEDClass A (EU MDR)
Ref 01.09.62.01.01.10Ref 01.09.62.01.01.11
by Zybio Inc.
Identity
- Device Name
- Blood Culture Positive Sample Pretreatment Kit EUDAMED
- Model / Reference
- 01.09.62.01.01.10 EUDAMED01.09.62.01.01.11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262869071 EUDAMED06973262869118 EUDAMED
- Basic UDI-DI
- 69732628600031ZH EUDAMED
- EMDN Code
- W010499 MICROBIOLOGY TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Blood Culture Positive Sample Pretreatment Kit by Zybio 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 | 69732628600031ZH | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f26bfa47-d57d-46d9-821e-7403574f7d34 61 fields · synced Jul 9, 2026
- EUDAMED 5bb78dfe-666c-4691-b351-69c011dba668 61 fields · synced May 18, 2026