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Sample Diluent
EUDAMEDClass A (EU MDR)
Ref 1.6mL×50Model 1.6mL/tube×25, 1.6mL/tube×50, 1.6mL/tube×100, 2.8L/barrel, 5L/barrel, 10L/barrel, 20L/barrel, 2.8L/barrel ×2, 5L/barrel ×2
Identity
- Trade Name
- Sample Diluent EUDAMED
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- 1.6mL/tube×25, 1.6mL/tube×50, 1.6mL/tube×100, 2.8L/barrel, 5L/barrel, 10L/barrel, 20L/barrel, 2.8L/barrel ×2, 5L/barrel ×2 EUDAMED1.6mL×50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942028501470 EUDAMED
- Basic UDI-DI
- 697052264SJPOX0003UP EUDAMED
- Direct Marketing DI
- 06942028501470 EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES 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
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Sample Diluent by Sichuan Orienter 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 | 697052264SJPOX0003UP | Class A | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 6e3db42b-8d71-49f1-a10c-a7f54313f145 61 fields · synced Jun 18, 2026