← Back to catalogue
Serum Amyloid A Protein Control
EUDAMEDClass IVD General (EU MDR)
Ref MY-0006-01Model Control 1：1×1.0mLRef MY-0006-03Model 2×1.0mL（Control 1, Control 2）
Identity
- Trade Name
- Serum Amyloid A Protein Control EUDAMED
- Device Name
- Serum Amyloid A Protein Control EUDAMED
- Model / Reference
- Control 1：1×1.0mL EUDAMEDMY-0006-01 EUDAMED2×1.0mL（Control 1, Control 2） EUDAMEDMY-0006-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970493098911 EUDAMED06970493092858 EUDAMED
- Basic UDI-DI
- B-06970493098911 EUDAMEDB-06970493092858 EUDAMED
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Serum Amyloid A Protein Control by Shenzhen Dymind Biotechnology Co., Ltd. — 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-06970493098911 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED 802cab31-a459-4576-956a-a172ca070176 61 fields · synced Jul 10, 2026
- EUDAMED d28298ae-5120-4912-8207-a244672f8553 61 fields · synced Jul 10, 2026