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Medlance Plus
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7042Model type 553-556Ref 8626Model 547Ref 8628Model type 549Ref 7044Model Type 553-556Ref 7046
Identity
- Trade Name
- Medlance Plus EUDAMEDMedlance EUDAMEDMedlance Plus, safety lancet FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Safety lancet EUDAMEDSterile,single-use safety lancets for capillary blood sampling. FDA UDI
- Model / Reference
- type 553-556 EUDAMED7042 EUDAMED547 EUDAMED8626 EUDAMEDtype 549 EUDAMED8628 EUDAMED7044 EUDAMED7046 EUDAMEDUniversal, 21G 1.8mm FDA UDISpecial, blade 0.8 mm 2.0 mm FDA UDI
- Description
- Sterile,single-use safety lancets for capillary blood sampling. FDA UDI
Identifiers
- Catalog Number
- 7044 FDA UDI7046 FDA UDI
- Primary DI / UDI-DI
- 05903999602796 EUDAMED05907996096145 EUDAMED05903999600457 EUDAMED05907506237112 EUDAMEDFDA UDI05907506237136 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05903999602796 EUDAMEDB-05907996096145 EUDAMEDB-05903999600457 EUDAMEDB-05907506237112 EUDAMEDB-05907506237136 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
- Sweden EUDAMEDFinland EUDAMEDFrance 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood lancet, single-use
Medlance Plus by Htl Strefa S A — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood lancet, single-use.
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- Safety Lancet (28G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
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-05903999602796 | 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 (7)
- EUDAMED 169f98c2-ef10-4660-a634-d7de0fa2f86e 61 fields · synced Jul 31, 2026
- EUDAMED 9d7ba9aa-8fcc-423e-9892-76f08171f680 61 fields · synced May 16, 2026
- EUDAMED 4b0b710d-c1ac-4ed7-aa2a-eb8b419252cb 61 fields · synced May 17, 2026
- FDA UDI 80ba8945-833a-414c-bb2d-cb1dc3fc9006 35 fields · synced May 30, 2026
- FDA UDI b0e35dbb-8672-4c28-8192-1e030dfb01d7 35 fields · synced May 30, 2026
- EUDAMED 039f25d6-1d08-4efd-876a-464dfe681858 61 fields · synced Jul 24, 2026
- EUDAMED 66feca01-ea90-49c9-99c4-8a891b0d2bbf 61 fields · synced Jul 31, 2026