Identity
- Trade Name
- Light Source RLED-81 EUDAMED
- Device Name
- Light Source EUDAMED
- Model / Reference
- RLED-81 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580137732648 EUDAMED
- Basic UDI-DI
- 458013773E0024C EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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: Endoscopic light source unit, line-powered
Light Source RLED-81 by Machida Endoscope Co., Ltd. — 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 | 458013773E0024C | Class I | Active |
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Manufacturer
- Manufacturer
- Machida Endoscope Co., Ltd.
- EUDAMED SRN
- JP-MF-000008990
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 982f269e-73b7-4185-8a0b-c4c684e31d63 61 fields · synced Jul 12, 2026