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GlucoRx Lite
EUDAMEDClass IIa (EU MDR)
Ref SL-23-18M2Model Type A, Type B, Type C, Type T, Type MRef BL-28GRef SL-28-18M2Ref BL-30GRef BL-33GRef BL-32G
Identity
- Trade Name
- GlucoRx Lite EUDAMEDGlucoRx EUDAMED
- Device Name
- Safety Blood Lancets EUDAMEDBlood Lancets EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-23-18M2 EUDAMEDBL-28G EUDAMEDSL-28-18M2 EUDAMEDBL-30G EUDAMEDBL-33G EUDAMEDBL-32G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978111922587 EUDAMED06978111925564 EUDAMED06978111922594 EUDAMED06978111922556 EUDAMED06978111925588 EUDAMED06978111925571 EUDAMED06978111926165 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED697122740BLX9 EUDAMED
- Unit of Use DI
- 86978111922583 EUDAMED86978111925560 EUDAMED86978111922590 EUDAMED86978111922552 EUDAMED86978111925584 EUDAMED86978111925577 EUDAMED86978111926161 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
GlucoRx Lite by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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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 (7)
- EUDAMED 4bb5a871-245c-4f32-9e25-d188260dfbe5 61 fields · synced Jul 21, 2026
- EUDAMED bde4e6d4-2fc6-4605-a6ea-38870eb06643 61 fields · synced May 17, 2026
- EUDAMED 5d7f6f3f-09c3-4345-8184-5d712cceaa0f 61 fields · synced May 17, 2026
- EUDAMED 859d8a5c-9833-46ae-8c61-bfcb434a5930 61 fields · synced May 17, 2026
- EUDAMED a59b42cc-d91f-45a8-a63f-7ef47edf44bd 61 fields · synced May 17, 2026
- EUDAMED 63dcd611-2112-43b7-ae9c-2d9b05532319 61 fields · synced May 18, 2026
- EUDAMED f88dccde-9a2f-4695-a033-7a53a79c33f7 61 fields · synced May 19, 2026