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Willcare
EUDAMEDClass IIa (EU MDR)
Ref IPN-32-4Ref IPN-32-6Ref BL-30GRef IPN-32-5
Identity
- Trade Name
- Willcare EUDAMED
- Device Name
- Insulin Pen Needles EUDAMEDBlood Lancets EUDAMED
- Model / Reference
- IPN-32-4 EUDAMEDIPN-32-6 EUDAMEDBL-30G EUDAMEDIPN-32-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971227408488 EUDAMED06971227408501 EUDAMED06975965299834 EUDAMED06971227408495 EUDAMED
- Basic UDI-DI
- 697122740IPNPZ EUDAMED697122740BLX9 EUDAMED
- Unit of Use DI
- 86971227408484 EUDAMED86971227408507 EUDAMED86975965299830 EUDAMED86971227408491 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Willcare by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697122740IPNPZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED e53828a4-dd0d-4cde-add2-46e71b90d6ca 61 fields · synced Oct 6, 2026
- EUDAMED 456c9aaa-b638-49cd-b179-418aef94854e 61 fields · synced May 18, 2026
- EUDAMED 1ba64cf0-8258-4f1a-9c61-1831278acbb4 61 fields · synced May 18, 2026
- EUDAMED 924c055a-aaf7-4c98-adbb-c27a6e9091e9 61 fields · synced May 18, 2026