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Sample Storage Reagent
EUDAMEDClass A (EU MDR)
Ref S10013E-48AModel S10013ERef X1004E-48-3Model X1004ERef X1001E-1Model X1001ERef X1003E-24-2Model X1003ERef X1003E-48-1Ref X1002E-24Model X1002ERef X1003E-24-3Ref X1002E-48-6Ref X1002E-24-6Ref X1002E-48-3Ref X1002E-24-2Ref X1003E-48-6Ref S10013E-48BRef X1006E-300Model X1006ERef X1004E-96-1Ref X1004E-24-6
Identity
- Trade Name
- Sample Storage Reagent EUDAMED
- Device Name
- Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) EUDAMEDSample Storage Reagent EUDAMED
- Model / Reference
- S10013E EUDAMEDS10013E-48A EUDAMEDX1004E EUDAMEDX1004E-48-3 EUDAMEDX1001E EUDAMEDX1001E-1 EUDAMEDX1003E EUDAMEDX1003E-24-2 EUDAMEDX1003E-48-1 EUDAMEDX1002E EUDAMEDX1002E-24 EUDAMEDX1003E-24-3 EUDAMEDX1002E-48-6 EUDAMEDX1002E-24-6 EUDAMEDX1002E-48-3 EUDAMEDX1002E-24-2 EUDAMEDX1003E-48-6 EUDAMEDS10013E-48B EUDAMEDX1006E EUDAMEDX1006E-300 EUDAMEDX1004E-96-1 EUDAMEDX1004E-24-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792714861 EUDAMED06955792713888 EUDAMED06955792713567 EUDAMED06955792713604 EUDAMED06955792713833 EUDAMED06955792713574 EUDAMED06955792713611 EUDAMED06955792714236 EUDAMED06955792714205 EUDAMED06955792714229 EUDAMED06955792714182 EUDAMED06955792713857 EUDAMED06955792714878 EUDAMED06955792714021 EUDAMED06955792713901 EUDAMED06955792713659 EUDAMED
- Basic UDI-DI
- 69557927S10013E00001GS EUDAMED69557927X1004E000001R9 EUDAMED69557927X1001E000001PG EUDAMED69557927X1003E000001QN EUDAMED69557927X1002E000001Q3 EUDAMED69557927X1006E000001SF EUDAMED
- Direct Marketing DI
- 06955792713567 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 EUDAMEDRomania EUDAMEDPoland EUDAMEDItaly EUDAMEDIreland EUDAMEDIceland 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
EUDAMEDEUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Sample Storage Reagent by Sansure Biotech Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 69557927S10013E00001GS | 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 (16)
- EUDAMED 27714f4d-9c6d-4342-9d24-e463402027fe 61 fields · synced Aug 3, 2026
- EUDAMED 204c4687-f843-4407-aebb-65002f1b6c92 61 fields · synced May 16, 2026
- EUDAMED 512d6d12-2f73-42b6-aaf0-6173620f8786 61 fields · synced May 16, 2026
- EUDAMED c876da09-a933-4ff1-8007-10bdb0b7cdf4 61 fields · synced May 16, 2026
- EUDAMED 535a23ed-d609-478a-97e0-0465f6d7d802 61 fields · synced May 16, 2026
- EUDAMED 20a7f22d-6675-479c-ad6b-057661084420 61 fields · synced May 17, 2026
- EUDAMED 77304da8-f470-435d-99ab-2ec7d6c86a45 61 fields · synced May 17, 2026
- EUDAMED b5f2c58a-a059-42eb-bbb6-7363e3423ac1 61 fields · synced May 17, 2026
- EUDAMED 78676d78-d638-4f8d-8d8e-398d6d069ff6 61 fields · synced May 17, 2026
- EUDAMED a6e5956a-45a4-496c-b41a-baee1c0206ec 61 fields · synced May 18, 2026
- EUDAMED f99dcd24-65b5-48ba-9600-826c8a1c62c3 61 fields · synced May 18, 2026
- EUDAMED ac02137c-4100-4978-9a9b-9c9bf6e54355 61 fields · synced May 18, 2026
- EUDAMED d3d590f4-89d5-4f1a-bd51-d9db493adaf4 61 fields · synced May 18, 2026
- EUDAMED 09cd4974-76f6-4eb5-bc1f-bb89fdb72cca 61 fields · synced May 19, 2026
- EUDAMED 284ecdff-1370-410c-ba8f-df5d4272bf6d 61 fields · synced May 19, 2026
- EUDAMED 5658df55-6ed7-4fe4-bb76-d0f8893cadfb 61 fields · synced May 19, 2026