Identity
- Trade Name
- Portable LED Light Source RLED-30 EUDAMEDMACHIDA FDA UDI
- Generic Name
- Endoscopic light source unit, battery-powered FDA UDI
- Device Name
- Portable LED Light Source EUDAMED
- Model / Reference
- RLED-30 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580137732617 EUDAMEDFDA UDI
- Basic UDI-DI
- 458013773E0014A EUDAMED
- FDA Product Code
- NTN FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, battery-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic light source unit, line-powered
Portable LED Light Source RLED-30 by Machida Endoscope Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458013773E0014A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 98155899-46e2-4a6d-8b75-860eba84582f 61 fields · synced Jul 9, 2026
- FDA UDI 4a38a631-5061-4180-b955-ac0e3c461b18 33 fields · synced May 26, 2026