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chemagic DNA CS200 kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 3207-0010
by Wallac Oy
Identity
- Trade Name
- chemagic DNA CS200 kit EUDAMEDFDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- chemagic DNA CS200 kit EUDAMEDFor DNA extraction from human plasma or blood. FDA UDI
- Model / Reference
- 3207-0010 EUDAMEDFDA UDI
- Description
- For DNA extraction from human plasma or blood. FDA UDI
Identifiers
- Catalog Number
- 3207-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147344208 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147chemagic_CSCW EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) 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
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
chemagic DNA CS200 kit by Wallac Oy — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147chemagic_CSCW | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED ae7ae67f-75df-40f0-81a6-64f0121feb31 61 fields · synced Jul 14, 2026
- FDA UDI 18308893-01e8-4257-846a-c390839003d6 35 fields · synced May 30, 2026