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Klinion
EUDAMEDClass IIa (EU MDR)
Ref SL-30-18MModel Type A, Type B, Type C, Type T, Type MRef SL-30-15MRef BL-28GRef SL-30-15TRef SL-30-18T
Identity
- Trade Name
- KLINION EUDAMED
- Device Name
- Safety Blood Lancets EUDAMEDBlood Lancets EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-30-18M EUDAMEDSL-30-15M EUDAMEDBL-28G EUDAMEDSL-30-15T EUDAMEDSL-30-18T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965296420 EUDAMED06975965296376 EUDAMED06975965293481 EUDAMED06975965293467 EUDAMED06975965296352 EUDAMED06975965296406 EUDAMED06975965296369 EUDAMED06975965296413 EUDAMED06975965296383 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED697122740BLX9 EUDAMED
- Unit of Use DI
- 86975965296426 EUDAMED86975965296372 EUDAMED86975965293487 EUDAMED86975965293463 EUDAMED86975965296358 EUDAMED86975965296402 EUDAMED86975965296365 EUDAMED86975965296419 EUDAMED86975965296389 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood lancet, single-use
Klinion 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 (9)
- EUDAMED 50d1c663-b598-457e-8c01-671abb7b338f 61 fields · synced Oct 6, 2026
- EUDAMED b1652671-39e2-491f-a471-955b8c1ecfdd 61 fields · synced May 17, 2026
- EUDAMED d7cccdc0-e4fd-4743-a3f7-a2aa2359d5c7 61 fields · synced May 17, 2026
- EUDAMED 7b6912a2-5df7-475c-8670-f430341d67ce 61 fields · synced May 17, 2026
- EUDAMED d24c14f9-5b68-46ce-9d15-25d05fa29cb1 61 fields · synced May 18, 2026
- EUDAMED 88a6b57d-3f73-4ddc-8fce-a9a95920e4cf 61 fields · synced May 18, 2026
- EUDAMED e02e95e9-2045-4938-a17a-c4cd145f5058 61 fields · synced May 19, 2026
- EUDAMED 3612d424-0a68-4be3-976d-17bba77724c2 61 fields · synced May 19, 2026
- EUDAMED 14810fb9-7385-44d3-a754-f6e15422ef1a 61 fields · synced May 19, 2026