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DNA Methylation-Lightning MagPrep
EUDAMEDClass A (EU MDR)
Ref 6 tests/kitModel (6 tests), (12 tests), (24 tests), (48 tests)
Identity
- Device Name
- DNA Methylation-Lightning MagPrep EUDAMED
- Model / Reference
- (6 tests), (12 tests), (24 tests), (48 tests) EUDAMED6 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975139678014 EUDAMED
- Basic UDI-DI
- 697513967OPBT0053K EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER 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
DNA Methylation-Lightning MagPrep by Beijing OriginPoly Bio-Tec Co., Ltd. — 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 | 697513967OPBT0053K | 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 (1)
- EUDAMED d63fa324-1192-4a86-8fd2-3e6d4d3ee110 61 fields · synced Jun 20, 2026