Identity
- Trade Name
- BabyLance Safety Heelstick EUDAMEDbabyLance FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- BabyLance Safety Heelstick EUDAMEDPreemie (Pink/White) 0.85 mm depth, Safety Heelstick FDA UDI
- Model / Reference
- BLN EUDAMEDBLP EUDAMEDFDA UDI
- Description
- Preemie (Pink/White) 0.85 mm depth, Safety Heelstick FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020123 EUDAMEDFDA UDI
- Basic UDI-DI
- 0814247001000QL EUDAMED
- 510(k) Number
- K223900 FDA UDI
- 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
- Italy 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood lancet, single-use
BabyLance Safety Heelstick by Clinical Innovations, LLC — 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 | 0814247001000QL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
- EUDAMED SRN
- US-MF-000031386
- Authorised Representative
- MVF FR-AR-000011189
Sources (2)
- EUDAMED 824f0e5c-a454-44d1-9801-c405259a49f6 61 fields · synced Jun 9, 2026
- FDA UDI f047d920-3225-473e-8751-341607a21c18 34 fields · synced May 30, 2026