Whole Blood DNA Extraction Kit (Magnetic Bead Method)
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) EUDAMEDFDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) EUDAMED
- Model / Reference
- SDK60110D-32T EUDAMEDSDK60110-48T(16*3) EUDAMEDSDK60110V EUDAMED48 Tests (16*3) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973342004439 EUDAMED06973342002589 EUDAMEDFDA UDI06973342006266 EUDAMED
- Basic UDI-DI
- 697334200SDK60110APKPH 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
Whole Blood 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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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697334200SDK60110APKPH | 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 (4)
- EUDAMED 377e57f0-5547-43ec-9628-1fb40d80b98a 61 fields · synced Jul 14, 2026
- EUDAMED d7d14cb1-418e-42d3-8146-d73411a71fe1 61 fields · synced May 19, 2026
- FDA UDI d306960d-e799-40ba-aad4-e08b88f86f4f 32 fields · synced May 29, 2026
- EUDAMED 740e449f-9f7b-4245-8925-4c035a677732 61 fields · synced Jul 14, 2026