← Back to catalogue
Sample Diluent
EUDAMEDClass A (EU MDR)
Ref 2.8L/ barrelModel 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 ×2Ref 2.8L/ 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 EUDAMED2.8L/ barrel EUDAMED2.8L/ barrel ×2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970522640111 EUDAMED06970522640128 EUDAMED
- Basic UDI-DI
- 697052264SJPOX0003UP EUDAMED
- Direct Marketing DI
- 06970522640111 EUDAMED06970522640128 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED ef5ae33e-a04c-4e2f-ab5f-f096ba2b0a94 61 fields · synced Aug 4, 2026
- EUDAMED 92082438-36d5-45bc-b26a-abbe2748a9e3 61 fields · synced May 18, 2026