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Sample Release Reagent
EUDAMEDClass A (EU MDR)
Ref S1014E-24Model S1014ERef S1013E-48Model S1013ERef S1011E-48Model S1011ERef S1014E-12A-PRef S1015E-24Ref S1012E-12A-PModel S1012ERef S1014E-48Ref S1014E-12B-PRef S1014E-96
Identity
- Trade Name
- Sample Release Reagent EUDAMED
- Device Name
- Sample Release Reagent EUDAMED
- Model / Reference
- S1014E EUDAMEDS1014E-24 EUDAMEDS1013E EUDAMEDS1013E-48 EUDAMEDS1011E EUDAMEDS1011E-48 EUDAMEDS1014E-12A-P EUDAMEDS1015E-24 EUDAMEDS1012E EUDAMEDS1012E-12A-P EUDAMEDS1014E-48 EUDAMEDS1014E-12B-P EUDAMEDS1014E-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792713499 EUDAMED06955792713482 EUDAMED06955792713451 EUDAMED06955792713963 EUDAMED06955792713529 EUDAMED06955792713949 EUDAMED06955792713505 EUDAMED06955792713970 EUDAMED06955792713512 EUDAMED
- Basic UDI-DI
- 69557927S1014E000001L7 EUDAMED69557927S1013E000001KL EUDAMED69557927S1011E000001JE EUDAMED69557927S1015E000001LS EUDAMED69557927S1012E000001JZ 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
Category: Nucleic acid extraction/isolation kit IVD
Sample Release 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 | 69557927S1014E000001L7 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (9)
- EUDAMED 9e159ced-0a34-454d-873a-a5382297e353 61 fields · synced Jul 30, 2026
- EUDAMED de516f5b-fa9c-4f3f-90a9-1307a4a8515c 61 fields · synced May 16, 2026
- EUDAMED 62b2fb49-c5d8-41b6-89c3-146f78cfd7d1 61 fields · synced May 16, 2026
- EUDAMED beaa1865-7d2d-469d-bbc8-31053cfdc7af 61 fields · synced May 16, 2026
- EUDAMED eb1a86e6-ed44-4573-a69b-10d458c199ef 61 fields · synced May 17, 2026
- EUDAMED 359ab144-dcda-4fdc-a867-8590202eda7f 61 fields · synced May 18, 2026
- EUDAMED 3e770042-24bc-46b7-ae71-880b5e2ba33a 61 fields · synced May 18, 2026
- EUDAMED 45150f35-f6fe-4609-a870-2c5674751dde 61 fields · synced May 18, 2026
- EUDAMED b1f0623f-d0a3-4240-a3ef-023a602fdcbb 61 fields · synced May 19, 2026