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Sample Diluent
EUDAMEDClass A (EU MDR)
Ref 10301002 Ref 10301002Model 90 mL/Vial
Identity
- Trade Name
- Sample Diluent EUDAMED
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- 10301002 EUDAMED90 mL/Vial EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070763237 EUDAMED
- Basic UDI-DI
- 697507076CLDiluentXC EUDAMED697507076000311RQ EUDAMED
- Direct Marketing DI
- 06975070763237 EUDAMED
- EMDN Code
- W0101070304 COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES) EUDAMEDW01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Sample Diluent by C-Luminary Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697507076CLDiluentXC | Class A | Active |
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Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED c45b733c-7d0f-44a2-b852-226096aaf6be 61 fields · synced Jul 26, 2026
- EUDAMED 1267f63a-b146-4932-a3cd-04bd674e5397 61 fields · synced Jul 26, 2026