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Sample Diluent
EUDAMEDClass A (EU MDR)
Ref D010 1x20mL/bottleModel Model: D001,D002,D003,D004,D005,D006,D007,D008,D009,D010,D011,D012
Identity
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- Model: D001,D002,D003,D004,D005,D006,D007,D008,D009,D010,D011,D012 EUDAMEDD010 1x20mL/bottle EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719601608 EUDAMED
- Basic UDI-DI
- 6972719600003AT EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
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 Nanjing RealMind Biotech 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 | 6972719600003AT | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED c4751580-72d2-4348-8927-8baf2f54191d 61 fields · synced Oct 8, 2026