Minicap Flex-Piercing Capiclean
EUDAMEDFDA UDIClass A (EU MDR)
by sebia
Identity
- Trade Name
- MINICAP FLEX-PIERCING CAPICLEAN EUDAMEDFDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- MINICAP FLEX-PIERCING CAPICLEAN EUDAMEDMINICAP FLEX-PIERCING CAPICLEAN IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082388 FDA UDI
- Model / Reference
- 2251 EUDAMEDFDA UDI
- Description
- MINICAP FLEX-PIERCING CAPICLEAN IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082388 FDA UDI
Identifiers
- Catalog Number
- 2251 FDA UDI
- Primary DI / UDI-DI
- 03607360022511 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607362251BUC8 EUDAMED
- FDA Product Code
- CEF FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1630 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Nucleic acid extraction/isolation kit IVD
Minicap Flex-Piercing Capiclean by Sebia — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3607362251BUC8 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (2)
- EUDAMED 8f8931a0-5411-4558-8434-cfba53cac947 61 fields · synced Jul 25, 2026
- FDA UDI d50a12d9-a6f7-4fe2-a8b3-a287080999cb 35 fields · synced May 30, 2026