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alphacheck professional Lancing Device
EUDAMEDClass I (EU MDR)
Ref -
by i-SENS, Inc.
Identity
- Trade Name
- alphacheck professional Lancing Device EUDAMED
- Device Name
- Lancing Device EUDAMED
- Model / Reference
- - EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260413710231 EUDAMED
- Basic UDI-DI
- 8806712LC001SF EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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: Device sterilization/disinfection container, reusable
alphacheck professional Lancing Device by i-SENS, Inc. — Class I — 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 | 8806712LC001SF | Class I | Active |
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Manufacturer
- Manufacturer
- i-SENS, Inc.
- EUDAMED SRN
- KR-MF-000009173
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 26aa2f70-3f5c-4b2b-9add-a39d2aec1055 61 fields · synced Jul 26, 2026