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Nucleic Acid Extraction-Purification Kit
EUDAMEDClass A (EU MDR)
Ref S10016E-32-AModel S10016ERef S10016E-48Ref S5005E-96Model S5005ERef S50015E-48AModel S50015ERef S5005E-48Ref S10016E-48CRef S50016E-24BModel S50016ERef S50016E-96ARef S10016E-24BRef S50015E-24BRef S50016E-12ARef S10018E-64T-N8Model S10018ERef S50015E-64-ARef S50015E-96ARef S50016E-64-ARef S10018E-48Ref S10016E-96BRef S5005E-48ARef S50015E-96Ref S50015E-48Ref S5005E-48BRef S10016E-48ARef S10016E-24ARef S50016E-24ARef S10016E-32-TRef S50015E-24ARef S50016E-64-TRef S10018E-96C-N96Ref S50016E-32-SRef S50016E-48CRef S50015E-48BRef S50016E-96BRef S10018E-96-N48Ref S10016E-96ARef S10018E-192-N96Ref S10016E-48BRef S10018E-96Ref S10018E-7200-N96Ref S50015E-32-T
Identity
- Trade Name
- Nucleic Acid Extraction-Purification Kit EUDAMED
- Device Name
- Nucleic Acid Extraction-Purification Kit EUDAMED
- Model / Reference
- S10016E EUDAMEDS10016E-32-A EUDAMEDS10016E-48 EUDAMEDS5005E EUDAMEDS5005E-96 EUDAMEDS50015E EUDAMEDS50015E-48A EUDAMEDS5005E-48 EUDAMEDS10016E-48C EUDAMEDS50016E EUDAMEDS50016E-24B EUDAMEDS50016E-96A EUDAMEDS10016E-24B EUDAMEDS50015E-24B EUDAMEDS50016E-12A EUDAMEDS10018E EUDAMEDS10018E-64T-N8 EUDAMEDS50015E-64-A EUDAMEDS50015E-96A EUDAMEDS50016E-64-A EUDAMEDS10018E-48 EUDAMEDS10016E-96B EUDAMEDS5005E-48A EUDAMEDS50015E-96 EUDAMEDS50015E-48 EUDAMEDS5005E-48B EUDAMEDS10016E-48A EUDAMEDS10016E-24A EUDAMEDS50016E-24A EUDAMEDS10016E-32-T EUDAMEDS50015E-24A EUDAMEDS50016E-64-T EUDAMEDS10018E-96C-N96 EUDAMEDS50016E-32-S EUDAMEDS50016E-48C EUDAMEDS50015E-48B EUDAMEDS50016E-96B EUDAMEDS10018E-96-N48 EUDAMEDS10016E-96A EUDAMEDS10018E-192-N96 EUDAMEDS10016E-48B EUDAMEDS10018E-96 EUDAMEDS10018E-7200-N96 EUDAMEDS50015E-32-T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792713314 EUDAMED06955792713277 EUDAMED06955792711679 EUDAMED06955792714137 EUDAMED06955792711662 EUDAMED06955792714250 EUDAMED06955792713697 EUDAMED06955792713772 EUDAMED06955792713307 EUDAMED06955792714083 EUDAMED06955792700208 EUDAMED06955792713444 EUDAMED06955792714113 EUDAMED06955792714168 EUDAMED06955792713727 EUDAMED06955792713390 EUDAMED06955792713819 EUDAMED06955792711686 EUDAMED06955792714069 EUDAMED06955792714052 EUDAMED06955792711693 EUDAMED06955792713352 EUDAMED06955792713291 EUDAMED06955792713680 EUDAMED06955792713321 EUDAMED06955792714076 EUDAMED06955792713734 EUDAMED06955792714304 EUDAMED06955792700215 EUDAMED06955792713765 EUDAMED06955792714144 EUDAMED06955792713789 EUDAMED06955792713413 EUDAMED06955792713802 EUDAMED06955792713420 EUDAMED06955792713796 EUDAMED06955792713406 EUDAMED06955792714267 EUDAMED06955792714106 EUDAMED
- Basic UDI-DI
- 69557927S10016E00001JD EUDAMED69557927S5005E000001PX EUDAMED69557927S50015E00001MQ EUDAMED69557927S50016E00001N9 EUDAMED69557927S10018E00001KF 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 EUDAMEDSpain 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
Nucleic Acid Extraction-Purification Kit by Sansure Biotech Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 69557927S10016E00001JD | 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 (39)
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