Identity
- Trade Name
- Lanmage EUDAMED
- Device Name
- Digital X-ray Radiography System EUDAMED
- Model / Reference
- 6600D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971297451698 EUDAMED
- Basic UDI-DI
- 697129745001LE EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
Lanmage by Shenzhen Lanmage Medical Technology Co., Ltd. — Class IIb — 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 | 697129745001LE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lanmage Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001122
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ceb36670-3f0c-4a8e-83c9-4ad586d1cab7 61 fields · synced Jun 18, 2026