Identity
- Trade Name
- chemagic Prepito-D EUDAMEDchemagic Prepito -D FDA UDI
- Generic Name
- Magnetic particle separation instrument IVD FDA UDI
- Device Name
- chemagic Prepito-D EUDAMEDThe chemagic Prepito-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques. FDA UDI
- Model / Reference
- 2022-0020 EUDAMEDFDA UDI
- Description
- The chemagic Prepito-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques. FDA UDI
Identifiers
- Catalog Number
- 2022-0020 FDA UDI
- Primary DI / UDI-DI
- 06438147332205 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147chemagic_Prep5J EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
- GMDN Term
- Magnetic particle separation instrument 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
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
chemagic Prepito-D 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_Prep5J | 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 6345b6a5-bb7b-4a9a-ad05-2f3b88610c7d 61 fields · synced Jul 22, 2026
- FDA UDI 51596b3c-03de-4ac0-bfc0-40efe5204059 34 fields · synced May 30, 2026