Identity
- Trade Name
- Safety Lancet PAII (21G) FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Safety Lancet PAII (Box of 100 Lancets), Sterilized with Irradiation FDA UDI
- Model / Reference
- PA2 21G EUDAMEDPA2 EUDAMEDLF-PAII-21 FDA UDI
- Description
- Safety Lancet PAII (Box of 100 Lancets), Sterilized with Irradiation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06949517003736 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06949517003736 EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Blood lancet, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Pa2 21g by Shandong Lianfa Medical Plastic Products Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06949517003736 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shandong Lianfa Medical Plastic Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000028790
- Authorised Representative
- Linkfar Healthcare GmbH DE-AR-000005107
Sources (2)
- EUDAMED 8ef462e5-0fdc-4f4d-b260-94587889d53d 61 fields · synced Jun 9, 2026
- FDA UDI 5cbe893b-9b05-4c42-be71-7ccef9899b14 33 fields · synced May 30, 2026