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Disposable Safety Lancets
EUDAMEDClass IIa (EU MDR)
Ref Press 21G 1.8mmRef B51530ARef Flex3 Plus 26GRef Press Plus 30G 1.4mmRef 05-232818 Press Plus 2818Ref Flex3 Plus 30GRef Flex3 Plus 28GRef Flex3 Plus 23GRef 05-052122 Press 21G 2.2mmRef Lite3 17G 2.0mmRef 05-172618 Impress 2618Ref 05-231823B Press Plus 18G 2.3mmRef 05-233015 Press Plus 3015Ref Press 28G 1.8mmRef Press 26G 1.8mmRef 05-111720B Lite3 1720Ref Press2 21G 1.8mmRef Press2 18G 1.8mmRef Elite 30G 1.4mmRef Flex3 Plus 21GRef 05-1526A Flex3 26GRef 05-112118 Lite3 2118Ref Press2 26G 1.8mmRef 05-062122Ref 05-231720B Press Plus 1720Ref 05-172122 Impress 2122Ref Lite3 26G 1.8mmRef 05-112818 Lite3 2818Ref 05-232122 Press Plus 2122Ref Ultra Safe 30G 1.4mmRef 05-232118 Press Plus 2118Ref Press 18G 1.8mm Ref 05-173015 Impress 3015Ref 05-232618 Press Plus 2618Ref 05-1528A Flex3 28GRef Lite4 30G 1.4mmRef Press Plus 23G 1.4mmRef 05-112618 Lite3 2618Ref Lite3 30G 1.8mmRef Lite3 28G 1.8mmRef 05-192128 Impress Pro 21G 1.8mmRef impress Pro 21G 1.8mmRef 05-052128Ref Ultra Safe 30G 1.4mm(加硅油)Ref Impress Pro 30G 1.4mmRef Elite 17G 1.6mmRef Press2 21G 2.2mm
Identity
- Trade Name
- Sterilance Disposable Safety Lancets EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMED
- Model / Reference
- Press 21G 1.8mm EUDAMEDB51530A EUDAMEDFlex3 Plus 26G EUDAMEDPress Plus 30G 1.4mm EUDAMED05-232818 Press Plus 2818 EUDAMEDFlex3 Plus 30G EUDAMEDFlex3 Plus 28G EUDAMEDFlex3 Plus 23G EUDAMED05-052122 Press 21G 2.2mm EUDAMEDLite3 17G 2.0mm EUDAMED05-172618 Impress 2618 EUDAMED05-231823B Press Plus 18G 2.3mm EUDAMED05-233015 Press Plus 3015 EUDAMEDPress 28G 1.8mm EUDAMEDPress 26G 1.8mm EUDAMED05-111720B Lite3 1720 EUDAMEDPress2 21G 1.8mm EUDAMEDPress2 18G 1.8mm EUDAMEDElite 30G 1.4mm EUDAMEDFlex3 Plus 21G EUDAMED05-1526A Flex3 26G EUDAMED05-112118 Lite3 2118 EUDAMEDPress2 26G 1.8mm EUDAMED05-062122 EUDAMED05-231720B Press Plus 1720 EUDAMED05-172122 Impress 2122 EUDAMEDLite3 26G 1.8mm EUDAMED05-112818 Lite3 2818 EUDAMED05-232122 Press Plus 2122 EUDAMEDUltra Safe 30G 1.4mm EUDAMED05-232118 Press Plus 2118 EUDAMEDPress 18G 1.8mm EUDAMED05-173015 Impress 3015 EUDAMED05-232618 Press Plus 2618 EUDAMED05-1528A Flex3 28G EUDAMEDLite4 30G 1.4mm EUDAMEDPress Plus 23G 1.4mm EUDAMED05-112618 Lite3 2618 EUDAMEDLite3 30G 1.8mm EUDAMEDLite3 28G 1.8mm EUDAMED05-192128 Impress Pro 21G 1.8mm EUDAMEDimpress Pro 21G 1.8mm EUDAMED05-052128 EUDAMEDUltra Safe 30G 1.4mm(加硅油) EUDAMEDImpress Pro 30G 1.4mm EUDAMEDElite 17G 1.6mm EUDAMEDPress2 21G 2.2mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630118101 EUDAMED16945630122894 EUDAMED16945630138673 EUDAMED16945630138819 EUDAMED16945630130882 EUDAMED16945630138697 EUDAMED16945630138680 EUDAMED16945630138666 EUDAMED16945630133876 EUDAMED16945630118033 EUDAMED16945630130967 EUDAMED16945630116671 EUDAMED16945630130899 EUDAMED16945630133913 EUDAMED16945630118125 EUDAMED16945630118118 EUDAMED16945630130998 EUDAMED16945630117944 EUDAMED16945630118088 EUDAMED16945630138734 EUDAMED16945630138604 EUDAMED16945630131063 EUDAMED16945630131001 EUDAMED16945630117937 EUDAMED06945630121951 EUDAMED16945630130844 EUDAMED16945630130950 EUDAMED16945630118057 EUDAMED16945630131025 EUDAMED16945630130868 EUDAMED16945630138888 EUDAMED16945630130851 EUDAMED16945630118149 EUDAMED16945630130981 EUDAMED16945630130875 EUDAMED16945630131070 EUDAMED16945630138925 EUDAMED16945630138789 EUDAMED16945630131018 EUDAMED16945630138932 EUDAMED16945630118071 EUDAMED16945630118064 EUDAMED16945630131780 EUDAMED16945630138246 EUDAMED16945630125239 EUDAMED16945630138796 EUDAMED16945630138895 EUDAMED16945630138970 EUDAMED16945630138710 EUDAMED16945630118019 EUDAMED16945630138628 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED6945630105DVB EUDAMED
- Unit of Use DI
- 06945630118104 EUDAMED06945630122897 EUDAMED06945630138676 EUDAMED06945630138812 EUDAMED06945630130885 EUDAMED06945630138690 EUDAMED06945630138683 EUDAMED06945630138669 EUDAMED06945630133879 EUDAMED06945630118036 EUDAMED06945630130960 EUDAMED06945630116674 EUDAMED06945630130892 EUDAMED06945630133916 EUDAMED06945630118128 EUDAMED06945630118111 EUDAMED06945630130991 EUDAMED06945630117947 EUDAMED06945630118081 EUDAMED06945630138737 EUDAMED06945630138607 EUDAMED06945630131066 EUDAMED06945630131004 EUDAMED06945630117930 EUDAMED06945630130847 EUDAMED06945630130953 EUDAMED06945630118050 EUDAMED06945630131028 EUDAMED06945630130861 EUDAMED06945630138881 EUDAMED06945630130854 EUDAMED06945630118142 EUDAMED06945630130984 EUDAMED06945630130878 EUDAMED06945630131073 EUDAMED06945630138928 EUDAMED06945630138782 EUDAMED06945630131011 EUDAMED06945630138935 EUDAMED06945630118074 EUDAMED06945630118067 EUDAMED06945630131783 EUDAMED06945630138249 EUDAMED06945630125232 EUDAMED06945630138799 EUDAMED06945630138898 EUDAMED06945630138973 EUDAMED06945630138713 EUDAMED06945630118012 EUDAMED06945630138621 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDFrance EUDAMEDBelgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Safety Lancets by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6945630105BH | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (51)
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- EUDAMED bd78a109-7200-4f4b-a300-bbdfd09fb607 61 fields · synced May 19, 2026
- EUDAMED a28ed408-0dfd-426b-b971-8543192b4a1a 61 fields · synced May 19, 2026