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Nucleic Acid Extraction Kit
EUDAMEDClass A (EU MDR)
Ref P08502T2032Ref P09001T2064Ref P08808T2048Ref P08508T2001Ref P08412T2096Ref PL08816T2040Ref P14004T2048Ref P08405T2064Ref P08305T2096Ref P08901T2001Ref P08401T2032Ref P08301T2001Ref P08503T2064Ref P08805T2064Ref P09005T2024Ref P08802T2096Ref P08910T2024Ref P08505T2096Ref P08501T2001Ref P09102T2096Ref PL08501T2012Ref P01911P2064Ref P08810T2096Ref P08802T2001Ref P01913P2064Ref P01913T2064Ref P01919P2064Ref P08801T2032Ref P08403T2064Ref P08801T2064Ref PL08813T2064Ref P085T00501Ref P09109T2024Ref PM080019T2040Ref P08309T2064Ref P08603T2064Ref P08502T2064Ref P09105T2064Ref P01914T2096Ref P09105T2001Ref P08414T2096Ref P01911P2096Ref P09101T2001Ref P14003T2001Ref P08604T2064Ref P08606T2096 Ref P08404T2064Ref P08406T2064Ref P08801T2001Ref P08408T2096
Identity
- Device Name
- Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- P08502T2032 EUDAMEDP09001T2064 EUDAMEDP08808T2048 EUDAMEDP08508T2001 EUDAMEDP08412T2096 EUDAMEDPL08816T2040 EUDAMEDP14004T2048 EUDAMEDP08405T2064 EUDAMEDP08305T2096 EUDAMEDP08901T2001 EUDAMEDP08401T2032 EUDAMEDP08301T2001 EUDAMEDP08503T2064 EUDAMEDP08805T2064 EUDAMEDP09005T2024 EUDAMEDP08802T2096 EUDAMEDP08910T2024 EUDAMEDP08505T2096 EUDAMEDP08501T2001 EUDAMEDP09102T2096 EUDAMEDPL08501T2012 EUDAMEDP01911P2064 EUDAMEDP08810T2096 EUDAMEDP08802T2001 EUDAMEDP01913P2064 EUDAMEDP01913T2064 EUDAMEDP01919P2064 EUDAMEDP08801T2032 EUDAMEDP08403T2064 EUDAMEDP08801T2064 EUDAMEDPL08813T2064 EUDAMEDP085T00501 EUDAMEDP09109T2024 EUDAMEDPM080019T2040 EUDAMEDP08309T2064 EUDAMEDP08603T2064 EUDAMEDP08502T2064 EUDAMEDP09105T2064 EUDAMEDP01914T2096 EUDAMEDP09105T2001 EUDAMEDP08414T2096 EUDAMEDP01911P2096 EUDAMEDP09101T2001 EUDAMEDP14003T2001 EUDAMEDP08604T2064 EUDAMEDP08606T2096 EUDAMEDP08404T2064 EUDAMEDP08406T2064 EUDAMEDP08801T2001 EUDAMEDP08408T2096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895472067 EUDAMED06970895472616 EUDAMED06970895472326 EUDAMED06970895472784 EUDAMED06970895473026 EUDAMED06970895472852 EUDAMED06970895472883 EUDAMED06970895472333 EUDAMED06970895472197 EUDAMED06970895472609 EUDAMED06970895472142 EUDAMED06970895472388 EUDAMED06970895473040 EUDAMED06970895472692 EUDAMED06970895472647 EUDAMED06970895472081 EUDAMED06970895472579 EUDAMED06970895472418 EUDAMED06970895472722 EUDAMED06970895472760 EUDAMED06970895473156 EUDAMED06970895472128 EUDAMED06970895472272 EUDAMED06970895472463 EUDAMED06970895472296 EUDAMED06970895472340 EUDAMED06970895472371 EUDAMED06970895472241 EUDAMED06970895472210 EUDAMED06970895472593 EUDAMED06970895472845 EUDAMED06970895473170 EUDAMED06970895472890 EUDAMED06970895472470 EUDAMED06970895472425 EUDAMED06970895472012 EUDAMED06970895472159 EUDAMED06970895472937 EUDAMED06970895472135 EUDAMED06970895472821 EUDAMED06970895473095 EUDAMED06970895472319 EUDAMED06970895472586 EUDAMED06970895472807 EUDAMED06970895472814 EUDAMED06970895473132 EUDAMED06970895472029 EUDAMED06970895472098 EUDAMED06970895473057 EUDAMED06970895472180 EUDAMED06970895472913 EUDAMED06970895472289 EUDAMED06970895472708 EUDAMED06970895472630 EUDAMED
- Basic UDI-DI
- 697089547NAEK00R2 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
- Czechia EUDAMEDNetherlands 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
Nucleic Acid Extraction Kit by Jiangsu Mole Bioscience 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 | 697089547NAEK00R2 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (54)
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