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Lancing Device
EUDAMEDFDA UDIClass I (EU MDR)
Ref 02-2201Ref 02-2201 LDE4Ref 57574
Identity
- Trade Name
- SteriLance Lancing Device LDE 4 FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- Lancing Device EUDAMED
- Model / Reference
- 02-2201 EUDAMEDFDA UDI02-2201 LDE4 EUDAMED57574 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945630125560 EUDAMED06945630131042 EUDAMED06945630122415 EUDAMED06945630121937 EUDAMED06945630116148 EUDAMED06945630125256 EUDAMED06945630115721 EUDAMED16945630113236 FDA UDI
- Basic UDI-DI
- 6945630102BB EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Greece EUDAMEDPoland EUDAMEDNorthern Ireland EUDAMEDItaly EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
Yes
FDA UDI
Lancing Device by Sterilance Medical (Suzhou) Inc. — Class I — 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 | 6945630102BB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (8)
- EUDAMED 0e998923-fdf4-40d7-a9cd-ae44f32a0b36 61 fields · synced Aug 4, 2026
- EUDAMED efcca34b-11c0-4bcf-8b23-cb4afd7ec852 61 fields · synced May 17, 2026
- EUDAMED bf16906c-121b-4856-953b-5da3449e9f81 61 fields · synced May 17, 2026
- EUDAMED 5034b351-3b9c-470c-b6e5-2973c4cd789d 61 fields · synced May 17, 2026
- EUDAMED beaaccc4-3f9c-4745-ad33-a79e837fe559 61 fields · synced May 17, 2026
- EUDAMED 901da5a5-42e0-4a85-960f-d206af555b69 61 fields · synced May 18, 2026
- EUDAMED fb3dde52-7a10-4844-95cb-77649d16015d 61 fields · synced May 18, 2026
- FDA UDI 7c7ae561-a4aa-4dc6-b03b-aa7deaccd59f 32 fields · synced May 29, 2026