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neoheel
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1053TRef SteriHeel 0.65x1.4mmRef SteriHeel 1.14x2.80mmRef SteriHeel Plus 1.14x2.8mmRef LLAN10417Ref SteriHeel Plus 1.0x2.5mmRef Neoheel 1.00x2.50mmRef Heel Plus 0.65x1.4mmRef 1051PRef OctaHeel 2.00x3.00mmRef 30-108575 SteriHeel Plus 0.85x1.75mmRef Heel Plus 1.00x2.50mmRef 30-101025 SteriHeel Plus 1.0x2.5mmRef SteriHeel Plus 0.65x1.4mmRef 30-102030 SteriHeel Plus 2.0x3.0mmRef 1052NRef SteriHeel Plus 1.00x2.50mmRef Neoheel 0.85x1.75mm
Identity
- Trade Name
- neoheel EUDAMEDSteriLance Neoheel Heel Incision Safety Lancet FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- Heel Incision EUDAMEDSteriLance Neoheel Heel Incision Safety Lancet,0.85*1.75mm,50Lancets/box FDA UDI
- Model / Reference
- 1053T EUDAMEDSteriHeel 0.65x1.4mm EUDAMEDSteriHeel 1.14x2.80mm EUDAMEDSteriHeel Plus 1.14x2.8mm EUDAMEDLLAN10417 EUDAMEDSteriHeel Plus 1.0x2.5mm EUDAMEDNeoheel 1.00x2.50mm EUDAMEDHeel Plus 0.65x1.4mm EUDAMED1051P EUDAMEDOctaHeel 2.00x3.00mm EUDAMED30-108575 SteriHeel Plus 0.85x1.75mm EUDAMEDHeel Plus 1.00x2.50mm EUDAMED30-101025 SteriHeel Plus 1.0x2.5mm EUDAMEDSteriHeel Plus 0.65x1.4mm EUDAMED30-102030 SteriHeel Plus 2.0x3.0mm EUDAMED1052N EUDAMEDSteriHeel Plus 1.00x2.50mm EUDAMEDNeoheel 0.85x1.75mm EUDAMED05-108575 FDA UDI
- Description
- SteriLance Neoheel Heel Incision Safety Lancet,0.85*1.75mm,50Lancets/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16945630116091 EUDAMED16945630117975 EUDAMED16945630138352 EUDAMED16945630118170 EUDAMED16945630119061 EUDAMED16945630118163 EUDAMED16945630138444 EUDAMED16945630138420 EUDAMED16945630116077 EUDAMED16945630138512 EUDAMED16945630130929 EUDAMED16945630138543 EUDAMED16945630130912 EUDAMED16945630138376 EUDAMED16945630130936 EUDAMED16945630116084 EUDAMED16945630138529 EUDAMED16945630138390 EUDAMED16945630138437 EUDAMED16945630109024 FDA UDI
- Basic UDI-DI
- 6945630130BG EUDAMED
- Unit of Use DI
- 06945630116094 EUDAMED06945630117978 EUDAMED06945630138355 EUDAMED06945630118173 EUDAMED06945630119064 EUDAMED06945630118166 EUDAMED06945630138447 EUDAMED06945630138423 EUDAMED06945630116070 EUDAMED06945630138515 EUDAMED06945630130922 EUDAMED06945630138546 EUDAMED06945630130915 EUDAMED06945630138379 EUDAMED06945630130939 EUDAMED06945630116087 EUDAMED06945630138522 EUDAMED06945630138393 EUDAMED06945630138430 EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Manual blood lancing device, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Austria EUDAMEDBelgium 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
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
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
Category: Blood lancet, single-use
neoheel by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6945630130BG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (20)
- EUDAMED 18154e5c-8e27-4401-8b3f-6c1d7472a1ba 61 fields · synced Aug 3, 2026
- EUDAMED 0c85d0bf-7e06-4898-918b-bf9ae0577578 61 fields · synced May 16, 2026
- EUDAMED c8ec8a3c-7410-4f7b-babf-bed9003d3c61 61 fields · synced May 17, 2026
- EUDAMED 95adf4d8-ec01-4534-aa77-c75b53320b1f 61 fields · synced May 17, 2026
- EUDAMED d3e0204d-e001-488d-b7f0-d8bc049c6b98 61 fields · synced May 17, 2026
- EUDAMED e524dd91-d1a1-4439-815a-6f0b3dc39499 61 fields · synced May 17, 2026
- EUDAMED 462f076c-ae92-441e-a07e-f54e5e9ac2bb 61 fields · synced May 17, 2026
- EUDAMED 7e0cebb1-e597-4d73-8a21-c8b51e08fcb2 61 fields · synced May 17, 2026
- EUDAMED 93a638e1-f052-48d1-aad6-84f809bb6a15 61 fields · synced May 17, 2026
- EUDAMED 10599715-e2cb-4ba6-a789-ef1781ec7e22 61 fields · synced May 17, 2026
- EUDAMED be4c8ca4-1a9c-40a1-a65c-6997f23cfa32 61 fields · synced May 17, 2026
- EUDAMED 3aa6b0ee-025f-4839-bbf1-d744dc654983 61 fields · synced May 17, 2026
- EUDAMED b1eb627c-3f6c-4ff4-a478-225d16ad80e6 61 fields · synced May 17, 2026
- EUDAMED 0ae368b1-e03b-4b0b-8fcb-9bac9d5c40c5 61 fields · synced May 18, 2026
- EUDAMED a6c716c4-17e2-4559-a43b-efd6fd69b7bd 61 fields · synced May 18, 2026
- EUDAMED d289b630-10af-45ae-869c-a2b214e9f1f0 61 fields · synced May 18, 2026
- EUDAMED de437835-8eea-4990-8300-8315139a58d3 61 fields · synced May 18, 2026
- FDA UDI b11791dc-f93c-48bf-a6bc-56509ad462dd 33 fields · synced May 22, 2026
- EUDAMED 76603e96-5d64-4681-867c-f3d10a9711dd 61 fields · synced Jul 8, 2026
- EUDAMED 83672116-2d90-4e75-91d4-3892b15b3987 61 fields · synced Jul 12, 2026