Identity
- Device Name
- Scrub Typhus Detect™ IgM ELISA EUDAMED
- Model / Reference
- STMS-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++B379STMS1AA EUDAMED
- Basic UDI-DI
- B-++B379STMS1AA EUDAMED
- EMDN Code
- W0105011799 BACTERIOLOGY IMMUNOASSAY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
Scrub Typhus Detect™ IgM ELISA by InBios International, Inc. — Class IVD General — 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-++B379STMS1AA | Class IVD General | Active |
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Manufacturer
- Manufacturer
- InBios International, Inc.
- EUDAMED SRN
- US-MF-000020625
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 6b7d30df-bae7-469b-8722-f5d3f63bc19a 61 fields · synced Jun 19, 2026