Identity
- Trade Name
- Sterilance SteriHeel Plus Heel Incision Safety Lancet FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- Heel Incision EUDAMEDSterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.85*1.75mm. FDA UDI
- Model / Reference
- Heel Plus 2.00x3.00mm EUDAMED30-108575 FDA UDI
- Description
- Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.85*1.75mm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16945630138550 EUDAMED16945630110280 FDA UDI
- Basic UDI-DI
- 6945630130BG EUDAMED
- Unit of Use DI
- 06945630138553 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 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
Heel Incision by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 (2)
- EUDAMED 3ea2bc81-390e-45fb-858f-c2511b9673be 61 fields · synced Sep 18, 2026
- FDA UDI f1b075f9-5b2b-41bc-a74e-045d07f116f3 33 fields · synced May 25, 2026