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Sputum DNA Isolation Kit (Boiling Method)
EUDAMEDClass A (EU MDR)
Ref SDK60114-50T
Identity
- Trade Name
- Sputum DNA Isolation Kit (Boiling Method) EUDAMED
- Device Name
- Sputum DNA Isolation Kit (Boiling Method) EUDAMED
- Model / Reference
- SDK60114-50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973342006969 EUDAMED
- Basic UDI-DI
- 697334200SDK60114KM 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
- Germany 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
Sputum DNA Isolation Kit (Boiling Method) by Jiangsu Bioperfectus Technologies 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 | 697334200SDK60114KM | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 5abd8168-1aed-4704-9de7-f6ebc86a5857 61 fields · synced Jul 16, 2026