Identity
- Trade Name
- Accu-Chek Softclix FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- Accu-Chek Softclix Mailorder 100ct 12/cs FDA UDI
- Model / Reference
- 03789721001 FDA UDI
- Description
- Accu-Chek Softclix Mailorder 100ct 12/cs FDA UDI
Identifiers
- Catalog Number
- 03789721001 FDA UDI
- Primary DI / UDI-DI
- 00365702897106 FDA UDI
- FDA Product Code
- QRK FDA UDI
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood lancing device tipManual blood lancing device, reusable
Accu-Chek Softclix by Roche Diabetes Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Roche Diabetes Care, Inc.
Sources (1)
- FDA UDI f9f0b655-0bb6-4fb8-b778-e15fc49e8fff 34 fields · synced Jun 8, 2026