← Back to catalogue
Myoglobin Chemiluminescence Immunoassay Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref G105A08
Identity
- Trade Name
- Myoglobin Chemiluminescence Immunoassay Test Kit EUDAMED
- Device Name
- Myoglobin Chemiluminescence Immunoassay Test Kit EUDAMED
- Model / Reference
- G105A08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804814984 EUDAMED
- Basic UDI-DI
- B-06952804814984 EUDAMED
- EMDN Code
- W0102160702 MYOGLOBIN - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Myoglobin Chemiluminescence Immunoassay Test Kit by Assure Tech. (hangzhou) 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-06952804814984 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8cd63f5a-f0be-4521-8af8-5e90e9ddf5ca 61 fields · synced Jun 18, 2026