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Medlance Plus, safety lancet
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 7928Model Type 553-556Ref 7246Ref 7949Ref 7947Ref 7662
Identity
- Trade Name
- Medlance Plus, safety lancet EUDAMEDFDA 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 EUDAMED7928 EUDAMED7246 EUDAMED7949 EUDAMED7947 EUDAMED7662 EUDAMEDSpecial, blade 0.8 mm 2.0 mm FDA UDI
- Description
- Sterile,single-use safety lancets for capillary blood sampling. FDA UDI
Identifiers
- Catalog Number
- 7246 FDA UDI
- Primary DI / UDI-DI
- 05907506237204 EUDAMEDFDA UDI05903999603939 EUDAMED05903999603960 EUDAMED05903999603946 EUDAMED08426521290300 EUDAMED
- Basic UDI-DI
- B-05903999603939 EUDAMEDB-05907506237204 EUDAMEDB-05903999603960 EUDAMEDB-05903999603946 EUDAMEDB-08426521290300 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
- Latvia 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, safety lancet by Htl Strefa S A — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood lancet, single-use.
- Contact Activated Safety Lancet — NINGBO MEDSUN MEDICAL CO., LTD. · Class IIa
- TysonBio — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Safety Lancet (25G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- Safety Lancet (23G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- STERiLANCE — Sterilance Medical (Suzhou) Inc. · Class IIa
- Lite3 — Sterilance Medical (Suzhou) Inc. · Class IIa
- Safety Lancet (28G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
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 (6)
- FDA UDI 22769e8e-79a9-4447-ae8b-f3deb5258d94 34 fields · synced Jul 27, 2026
- EUDAMED 42edf640-2162-4c4f-a437-0311197e3ff6 61 fields · synced Jul 9, 2026
- EUDAMED 0a974629-d4f5-423f-821a-94d4954f8940 61 fields · synced Jul 12, 2026
- EUDAMED c9e781c7-1ea7-4527-9d1b-325792271d72 61 fields · synced Jul 13, 2026
- EUDAMED 0813845d-1179-42ac-920d-ee45942792a0 61 fields · synced Jul 22, 2026
- EUDAMED b3cc5239-1a9b-4cfa-82eb-de14faa6dad2 61 fields · synced Jul 27, 2026