Identity
- Trade Name
- droplet Genteel lancing device FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- The Droplet Genteel Lancing Device is used with disposable lancets to draw capillary blood from the fingertip or alternate sites for glucose testing or other testing utilizing small amount of blood. FDA UDI
- Model / Reference
- n/a FDA UDI
- Description
- The Droplet Genteel Lancing Device is used with disposable lancets to draw capillary blood from the fingertip or alternate sites for glucose testing or other testing utilizing small amount of blood. FDA UDI
Identifiers
- Catalog Number
- 9150 FDA UDI
- Primary DI / UDI-DI
- 05907996098774 FDA UDI
- 510(k) Number
- K153670 FDA UDI
- FDA Product Code
- FMK 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual blood lancing device, reusable
droplet Genteel lancing device by Htl Strefa S A — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, reusable.
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- Autolet — OWEN MUMFORD USA INCORPORATED · Class II
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- TeleRPM & Chronica — Mio Labs Inc.
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- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
Cleared under the same submission
K153670 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Htl Strefa S A
Sources (2)
- FDA UDI cdfd18a6-50f0-4029-b8fc-766d0e0d317b 35 fields · synced Jun 8, 2026
- EUDAMED 1 fields · synced May 25, 2026