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Magnetic Circulating DNA Maxi Kit
EUDAMEDClass A (EU MDR)
Ref 48 tests/kitModel (12 tests), (24 tests), (48 tests)Ref 24 tests/kitRef 12 tests/kit
Identity
- Device Name
- Magnetic Circulating DNA Maxi Kit EUDAMED
- Model / Reference
- (12 tests), (24 tests), (48 tests) EUDAMED48 tests/kit EUDAMED24 tests/kit EUDAMED12 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975139678137 EUDAMED06975139678120 EUDAMED06975139678113 EUDAMED
- Basic UDI-DI
- 697513967OPBT0083R 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
- Austria 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
Magnetic Circulating DNA Maxi Kit by Beijing OriginPoly Bio-Tec Co., Ltd. — 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 | 697513967OPBT0083R | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing OriginPoly Bio-Tec Co., Ltd.
- EUDAMED SRN
- CN-MF-000043242
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 743b6f5c-e4d5-4719-9d0f-22fc8feb5548 61 fields · synced Jul 29, 2026
- EUDAMED 4abbbe43-d58d-4800-806a-a69e11d41ef9 61 fields · synced May 19, 2026
- EUDAMED 8afe83d1-e129-4c24-bdcf-78b4e4b47454 61 fields · synced May 19, 2026