Identity
- Trade Name
- Insulin Delivery Device EUDAMED
- Device Name
- Insulin Delivery Device EUDAMED
- Model / Reference
- XLB01E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971953352994 EUDAMED
- Basic UDI-DI
- 697195335321202FMFXLB1EK4 EUDAMED
- EMDN Code
- A020203 CARTRIDGE SYRINGES EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Insulin Delivery Device by Gangan Medical Technology Jiangsu Co., LTD — Class IIb — 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 | 697195335321202FMFXLB1EK4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Gangan Medical Technology Jiangsu Co., LTD
- EUDAMED SRN
- CN-MF-000007635
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED e5d6cdcd-3ea6-4ecf-9af2-c7be86279a78 61 fields · synced Jun 19, 2026