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INSTI T. pallidum Test Controls
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 90-1032
Identity
- Trade Name
- INSTI T. pallidum Test Controls EUDAMED
- Device Name
- INSTI Test Control T. Pallidum CE en EUDAMED
- Model / Reference
- 90-1032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00686597202128 EUDAMED
- Basic UDI-DI
- B-00686597202128 EUDAMED
- EMDN Code
- W0105094001 CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
INSTI T. pallidum Test Controls by Biolytical Laboratories Inc. — Class IVD Annex II List A — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-00686597202128 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- bioLytical Laboratories Inc.
- EUDAMED SRN
- CA-MF-000023304
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d3ac433b-923a-4c64-937c-a289a2eaca81 61 fields · synced Jul 21, 2026