Identity
- Trade Name
- ergoLance EUDAMEDergoLance, safety lancet FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- safety lancet EUDAMEDErgoLance, safety lancets are sterile, single use medical devices intended for capillary blood sampling. FDA UDI
- Model / Reference
- type 450 EUDAMED8506 EUDAMED21G 2.0mm FDA UDI
- Description
- ErgoLance, safety lancets are sterile, single use medical devices intended for capillary blood sampling. FDA UDI
Identifiers
- Catalog Number
- 8506 FDA UDI
- Primary DI / UDI-DI
- 05907996091423 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05907996091423 EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Blood lancet, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ergoLance by Htl Strefa S A — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05907996091423 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (2)
- EUDAMED 7f6c9ba7-5b7f-435a-af22-9054fe43af8c 61 fields · synced Sep 18, 2026
- FDA UDI ad8aafe4-590b-4207-b783-da6910352c05 35 fields · synced May 30, 2026