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Control for Body Liquid
EUDAMEDClass IVD General (EU MDR)
Ref 3016128Model Level 2: 1×3.0mLRef 3016134Model Level 1: 1×3.0mL
Identity
- Trade Name
- Control for Body Liquid EUDAMED
- Device Name
- Control for Body Liquid EUDAMED
- Model / Reference
- Level 2: 1×3.0mL EUDAMED3016128 EUDAMEDLevel 1: 1×3.0mL EUDAMED3016134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794523556 EUDAMED06925794523549 EUDAMED
- Basic UDI-DI
- B-06925794523556 EUDAMEDB-06925794523549 EUDAMED
- EMDN Code
- W0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Control for Body Liquid by Dirui Industrial 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-06925794523556 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a1f276d5-50b3-4bef-836d-6ceed8f2c5c2 61 fields · synced Aug 4, 2026
- EUDAMED d1597347-16c6-459b-995d-b32e664839f0 61 fields · synced May 18, 2026