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Hamex
EUDAMEDClass IIa (EU MDR)
Ref SL-21-12MModel Type A, Type B, Type C, Type T, Type MRef SL-28-20MRef SL-21-20M2Ref SL-21-28MRef SL-30-15MRef SL-28-20M2Ref SL-28-16M2Ref SL-21-24M2Ref SL-23-18MRef SL-23-18M2
Identity
- Trade Name
- HAMEX EUDAMED
- Device Name
- Safety Blood Lancets EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-21-12M EUDAMEDSL-28-20M EUDAMEDSL-21-20M2 EUDAMEDSL-21-28M EUDAMEDSL-30-15M EUDAMEDSL-28-20M2 EUDAMEDSL-28-16M2 EUDAMEDSL-21-24M2 EUDAMEDSL-23-18M EUDAMEDSL-23-18M2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971227409492 EUDAMED06971227409546 EUDAMED06975965296888 EUDAMED06975965296895 EUDAMED06971227409522 EUDAMED06971227409553 EUDAMED06978111921603 EUDAMED06975965296932 EUDAMED06975965296918 EUDAMED06971227409539 EUDAMED06978111921597 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED
- Unit of Use DI
- 86971227409498 EUDAMED86971227409542 EUDAMED86975965296884 EUDAMED86975965296891 EUDAMED86971227409528 EUDAMED86971227409559 EUDAMED86978111921609 EUDAMED86975965296938 EUDAMED86975965296914 EUDAMED86971227409535 EUDAMED86978111921593 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood lancet, single-use
Hamex by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697122740SLYU | 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 (11)
- EUDAMED 4dfa7ca6-76ae-44d3-aac4-b83a60d2dc76 61 fields · synced Aug 2, 2026
- EUDAMED 0b45adc7-853e-45f4-bb7a-2e0ab1c61791 61 fields · synced May 17, 2026
- EUDAMED 96e4e4ea-01e4-4328-9d11-d322dfc588d7 61 fields · synced May 17, 2026
- EUDAMED 918c4bf4-2e8a-418e-bf24-5c730b682cb2 61 fields · synced May 17, 2026
- EUDAMED a11c9542-96ae-4f17-ae77-01713d35d62f 61 fields · synced May 18, 2026
- EUDAMED d8d95dd3-ac83-48a9-b69d-b1fc921235f3 61 fields · synced May 18, 2026
- EUDAMED 3864681a-20dc-4b22-9da6-e6c14d18315b 61 fields · synced May 18, 2026
- EUDAMED 29097a9d-bcdf-4050-8a3e-068374838154 61 fields · synced May 18, 2026
- EUDAMED ba4b1d84-ba72-43cf-a193-f944092a6528 61 fields · synced May 18, 2026
- EUDAMED a25aeb4e-c44d-4072-9361-b4ec404193e1 61 fields · synced May 18, 2026
- EUDAMED 184d0a4f-9ddd-4c03-b563-fbfb875df8a0 61 fields · synced May 18, 2026