Bacteria DNA Extraction Kit (Magnetic Bead Method)
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Bacteria DNA Extraction Kit (Magnetic Bead Method) EUDAMEDBacteria DNA Extraction Kit (Magnetic Bead Method) FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Bacteria DNA Extraction Kit (Magnetic Bead Method) EUDAMED
- Model / Reference
- SDK60108-96T EUDAMED96 Tests FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973342002534 EUDAMEDFDA UDI
- Basic UDI-DI
- 697334200SDK60108APKQW EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nucleic acid extraction/isolation kit IVD
Bacteria DNA Extraction Kit (Magnetic Bead Method) by Jiangsu Bioperfectus Technologies Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Nucleic acid extraction/isolation kit IVD.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697334200SDK60108APKQW | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 768db392-e02e-4c2b-b2e3-734d92a95c95 61 fields · synced Jul 12, 2026
- FDA UDI 81221508-382a-4cfa-b0f5-bcee9e423f68 32 fields · synced May 30, 2026