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Sample Storage Reagent X
EUDAMEDClass A (EU MDR)
Ref X1010E-48B-3Ref X1010E-48-1
Identity
- Device Name
- Sample Storage Reagent X EUDAMED
- Model / Reference
- X1010E-48B-3 EUDAMEDX1010E-48-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792714427 EUDAMED06955792714403 EUDAMED
- Basic UDI-DI
- 69557927X1010E000001PL EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Sample Storage Reagent X by Sansure Biotech Inc. — 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 | 69557927X1010E000001PL | Class A | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED e8b1bc76-08be-4655-951a-5a231b6cef06 61 fields · synced Jul 23, 2026
- EUDAMED 8903049f-9897-4c30-b406-d5d5cd1f8157 61 fields · synced May 18, 2026