Identity
- Trade Name
- RADI PREP Plus 48 FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic acid extraction and purification from various biological samples including tissue, cell culture, whole blood, serum, plasma, swab, Bacteria, yeast, etc. FDA UDI
- Model / Reference
- RADIPREP EUDAMEDKM003 EUDAMEDFDA UDI
- Description
- The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic acid extraction and purification from various biological samples including tissue, cell culture, whole blood, serum, plasma, swab, Bacteria, yeast, etc. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800204300102 EUDAMEDFDA UDI
- Basic UDI-DI
- 88002043RADIPREPSD EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Km003 by KH Medical Co., Ltd. — 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 | 88002043RADIPREPSD | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- KH Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000017883
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED c9a8b013-4567-4a51-97db-248b6677d060 61 fields · synced Jul 14, 2026
- FDA UDI 67c14582-6db4-43ca-b74b-59d91adfd289 34 fields · synced May 30, 2026