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Bacteria Genomic DNA Purification Kit
EUDAMEDClass A (EU MDR)
Ref 20T/Box (DT6) (Pre-filled), 1T/Strip × 20stripsModel 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips
Identity
- Trade Name
- Bacteria Genomic DNA Purification Kit EUDAMED
- Device Name
- Bacteria Genomic DNA Purification Kit EUDAMED
- Model / Reference
- 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips EUDAMED20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979458030218 EUDAMED
- Basic UDI-DI
- 697945803EH07PN 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
Bacteria Genomic DNA Purification Kit by Xi'an Huawei Technology 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 | 697945803EH07PN | Class A | Active |
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Manufacturer
- Manufacturer
- Xi'an Huawei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000051653
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED d15ba84e-d18c-4ee9-a571-d0ff965655df 61 fields · synced Jul 13, 2026
- EUDAMED d15ba84e-d18c-4ee9-a571-d0ff965655df-1 61 fields · synced Jun 10, 2026