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Bisulfite Conversion Kit (Spin Column)
EUDAMEDClass A (EU MDR)
Ref EP110192CERef EP110048CE
Identity
- Trade Name
- Bisulfite Conversion Kit (Spin Column) EUDAMED
- Device Name
- Bisulfite Conversion Kit (Spin Column) EUDAMED
- Model / Reference
- EP110192CE EUDAMEDEP110048CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975970650064 EUDAMED06975970650057 EUDAMED
- Basic UDI-DI
- 697597065022QG EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Bisulfite Conversion Kit (Spin Column) by Singlera Genomics (jiangsu) 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 | 697597065022QG | Class A | Active |
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Manufacturer
- Manufacturer
- Singlera Genomics (jiangsu) Ltd.
- EUDAMED SRN
- CN-MF-000033428
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 608e60fc-897a-46da-aa11-a66a3ae48de1 61 fields · synced Jul 19, 2026
- EUDAMED 80a3e8e1-5b1c-4613-89a6-2c2b1cf3bcec 61 fields · synced May 18, 2026
- EUDAMED f530ce2c-d5d2-49a1-a88d-665b6110e1dc 61 fields · synced Jun 20, 2026
- EUDAMED 725ea0b4-010e-4893-b5bc-fc12b4c9dd3d 61 fields · synced Jul 19, 2026