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Agglutination slide and tube tests with positive and negative controls, 8 x 5 m…
EUDAMEDClass IVD General (EU MDR)
Ref 101-0424
Identity
- Trade Name
- Agglutination slide and tube tests with positive and negative controls, 8 x 5 mL, 2 x 1 mL EUDAMED
- Device Name
- Agglutination slide and tube tests with positive and negative controls, 8 x 5 mL, 2 x 1 mL EUDAMED
- Model / Reference
- 101-0424 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-084360386316313EM EUDAMED
- Basic UDI-DI
- B-084360386316313EM EUDAMED
- EMDN Code
- W0105011799 BACTERIOLOGY IMMUNOASSAY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Agglutination slide and tube tests with positive and negative controls, 8 x 5 m… by Chronolab Systems, S.L. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-084360386316313EM | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Chronolab Systems, S.L.
- EUDAMED SRN
- ES-MF-000017043
Sources (1)
- EUDAMED 094cb01e-fea5-4ea5-a638-0a7ecfe6089a 61 fields · synced Oct 6, 2026