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Insti Hiv Antibody Self-Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 90-1076-003 and 90-1076-004
Identity
- Trade Name
- INSTI HIV ANTIBODY SELF-TEST EUDAMED
- Device Name
- INSTI HIV Self Test CE enfise 10 and INSTI HIV Self Test CE enfise 250 EUDAMED
- Model / Reference
- 90-1076-003 and 90-1076-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00686597201404 EUDAMED
- Basic UDI-DI
- B-00686597201404 EUDAMED
- EMDN Code
- W0105030402 HIV MULTIPLE ANTIBODY 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Insti Hiv Antibody Self-Test 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-00686597201404 | 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 94a100d4-8b13-4082-bdcb-0447dcedfb5c 61 fields · synced Jun 19, 2026