Identity
- Trade Name
- HEPRO.US Lancets MM1000 FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Sterile Lancets; Fine gauge 28G Tri-bevel tip Universal Design fits most lancing devices 1 Box of 50pcs FDA UDI
- Model / Reference
- Box LANCETS 50pcs FDA UDI
- Description
- Sterile Lancets; Fine gauge 28G Tri-bevel tip Universal Design fits most lancing devices 1 Box of 50pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854427007155 FDA UDI
- FDA Product Code
- FMK FDA UDI
- GMDN Term
- Blood lancet, single-use 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood lancet, single-useManual blood lancing device, single-use
HEPRO.US Lancets MM1000 by Hepro.us 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
- Hepro.us Inc.
Sources (1)
- FDA UDI 31633f30-cc8b-4f21-ae1a-dc57435022e7 33 fields · synced May 30, 2026