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DNA Isolation and Methylate Preparation Kit
EUDAMEDClass A (EU MDR)
Ref 12 tests/kitModel (12 tests), (24 tests), (48 tests)Ref 24 tests/kitRef 48 tests/kit
Identity
- Device Name
- DNA Isolation and Methylate Preparation Kit EUDAMED
- Model / Reference
- (12 tests), (24 tests), (48 tests) EUDAMED12 tests/kit EUDAMED24 tests/kit EUDAMED48 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975139678052 EUDAMED06975139678069 EUDAMED06975139678076 EUDAMED
- Basic UDI-DI
- 697513967OPBT0073P 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 Isolation and Methylate Preparation Kit 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 | 697513967OPBT0073P | 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 293a4faa-75ab-44eb-9e8f-a1be019b9f56 61 fields · synced Jul 22, 2026
- EUDAMED 5bd6ebcc-be2d-4638-992f-c49ecba78011 61 fields · synced May 18, 2026
- EUDAMED c4ff3b7f-9dee-4d5e-acad-7b3caa1993bb 61 fields · synced May 19, 2026