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Haemolance Plus
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7363Model type 420Ref 7927Model Type 420Ref 8866Ref 7925Ref 7926Ref 7366Ref 8861Ref 8737Ref 9179Ref 8736Ref 9173Ref 7924Ref 7922Ref 8859Ref 7372Ref 9176
Identity
- Trade Name
- Haemolance Plus EUDAMEDHaemolance Plus, safety lancet FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- safety lancet EUDAMEDSafety lancets are sterile, single use medical devices intended for capillary blood sampling. FDA UDI
- Model / Reference
- type 420 EUDAMED7363 EUDAMED7927 EUDAMED8866 EUDAMED7925 EUDAMED7926 EUDAMED7366 EUDAMED8861 EUDAMED8737 EUDAMED9179 EUDAMED8736 EUDAMED9173 EUDAMED7924 EUDAMED7922 EUDAMED8859 EUDAMED7372 EUDAMED9176 EUDAMEDNormal Flow, 21G 1.8mm FDA UDIHigh Flow, 18G 1.8mm FDA UDI
- Description
- Safety lancets are sterile, single use medical devices intended for capillary blood sampling. FDA UDI
Identifiers
- Catalog Number
- 7366 FDA UDI7372 FDA UDI7363 FDA UDI
- Primary DI / UDI-DI
- 05907506237389 EUDAMEDFDA UDI05907506237075 EUDAMEDFDA UDI05907506237457 EUDAMEDFDA UDI05903999603922 EUDAMED05903999604370 EUDAMED05903999603908 EUDAMED05903999603915 EUDAMED05903999604325 EUDAMED05907996099924 EUDAMED05903999601201 EUDAMED05907996099917 EUDAMED05907996099825 EUDAMED05903999603892 EUDAMED05903999603878 EUDAMED05903999604301 EUDAMED05907996099832 EUDAMED
- Basic UDI-DI
- B-05907506237389 EUDAMEDB-05903999603922 EUDAMEDB-05903999604370 EUDAMEDB-05903999603908 EUDAMEDB-05903999603915 EUDAMEDB-05907506237075 EUDAMEDB-05903999604325 EUDAMEDB-05907996099924 EUDAMEDB-05903999601201 EUDAMEDB-05907996099917 EUDAMEDB-05907996099825 EUDAMEDB-05903999603892 EUDAMEDB-05903999603878 EUDAMEDB-05903999604301 EUDAMEDB-05907506237457 EUDAMEDB-05907996099832 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
- Slovakia EUDAMEDLithuania EUDAMEDLatvia EUDAMEDSpain EUDAMEDEstonia EUDAMEDGermany EUDAMEDDenmark EUDAMEDCzechia 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
Haemolance 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.
- 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 Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05907506237389 | 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 (19)
- EUDAMED 88aa4bf6-c444-4148-b615-0105f6c9d6b4 61 fields · synced Aug 1, 2026
- FDA UDI b6a8e6ae-5e9d-4416-acb6-512bbdd19883 35 fields · synced May 29, 2026
- FDA UDI 3fdfd9ae-5a26-4346-b2c3-0b95c5f171ea 35 fields · synced May 29, 2026
- FDA UDI c6fc39e4-5eeb-47ba-9d19-7c838316d72e 35 fields · synced May 30, 2026
- EUDAMED 9a27d2cf-5100-4436-a5e1-1a1e3389c030 61 fields · synced Jun 20, 2026
- EUDAMED 8c35832a-b6f2-4159-91a3-fa44d34982b0 61 fields · synced Jul 9, 2026
- EUDAMED 14792d16-6d87-4d1e-bd70-0e0aa3c94394 61 fields · synced Jul 9, 2026
- EUDAMED d224201c-3e66-45dc-8cbc-34019d273f96 61 fields · synced Jul 10, 2026
- EUDAMED fc168a18-bd4d-4b5b-bd1d-d3ed4d926826 61 fields · synced Jul 10, 2026
- EUDAMED bf28fd2d-6d63-4df9-b1f2-5e83d40aeae2 61 fields · synced Jul 10, 2026
- EUDAMED 4b3fd3a0-9398-466a-8de1-330f17d91613 61 fields · synced Jul 10, 2026
- EUDAMED 97c7cec7-47ae-465f-841c-7437f10ab9ae 61 fields · synced Jul 11, 2026
- EUDAMED c7f6421b-914b-436f-852e-620d2a248c18 61 fields · synced Jul 15, 2026
- EUDAMED 753e0c94-ea8a-486d-a7a5-4efe648338b8 61 fields · synced Jul 16, 2026
- EUDAMED 4634445f-3c83-4ad9-be0e-6424de397cf4 61 fields · synced Jul 22, 2026
- EUDAMED d7e7c8b3-e612-4a16-89ba-494dc0dc2a05 61 fields · synced Jul 23, 2026
- EUDAMED f27a039d-7f14-4c64-aa96-6640e45fa0d0 61 fields · synced Jul 25, 2026
- EUDAMED 94e07128-0b2f-4f44-b5e6-686b3649fe27 61 fields · synced Jul 31, 2026
- EUDAMED e76c915c-cee8-46c0-a7e0-d51811eb8684 61 fields · synced Aug 1, 2026