Identity
- Trade Name
- Rigid Laryngoscope LY-CS30 EUDAMEDMACHIDA FDA UDI
- Generic Name
- Laryngostroboscope FDA UDI
- Device Name
- Rigid Laryngoscope EUDAMED
- Model / Reference
- LY-CS30 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580137730279 EUDAMEDFDA UDI
- Basic UDI-DI
- 458013773B0013M EUDAMED
- FDA Product Code
- EQL FDA UDI
- EMDN Code
- Z12021010 LARYNGOSTROBOSCOPES EUDAMED
- GMDN Term
- Laryngostroboscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4750 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Rigid Laryngoscope LY-CS30 by Machida Endoscope Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458013773B0013M | 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 f3dd9d56-7680-4f30-8977-f2822f698059 61 fields · synced Jun 18, 2026
- FDA UDI 323ee066-6093-4cf6-b133-35f49ec78f1a 33 fields · synced May 30, 2026