← Back to catalogue
Sangtec-100 Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013435Model 1×100 Tests/kitRef 3014258Model 2×50 Tests/kit
Identity
- Trade Name
- Sangtec-100 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Sangtec-100 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×100 Tests/kit EUDAMED3013435 EUDAMED2×50 Tests/kit EUDAMED3014258 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794571410 EUDAMED06942202224324 EUDAMED
- Basic UDI-DI
- B-06925794571410 EUDAMEDB-06942202224324 EUDAMED
- EMDN Code
- W01021702 PROTEIN S-100 B EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Sangtec-100 Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — 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-06925794571410 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f21f41ac-8356-49c4-905e-60214b2fdcf8 61 fields · synced Jul 11, 2026
- EUDAMED 3b39fbfe-3b69-4754-84b3-d0c35453e12f 61 fields · synced May 19, 2026