Identity
- Trade Name
- LARYNGEAL STROBE 9400 EUDAMEDN/A FDA UDI
- Generic Name
- Laryngostroboscope FDA UDI
- Device Name
- 9400 LARYNGOSTROBOSCOPE EUDAMEDLARYNGEAL STROBE FDA UDI
- Model / Reference
- 9400 EUDAMEDFDA UDI
- Description
- LARYNGEAL STROBE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333240685 EUDAMEDFDA UDI
- Basic UDI-DI
- 49613330394002H EUDAMED
- Direct Marketing DI
- 04961333240685 EUDAMED
- 510(k) Number
- K921184 FDA UDI
- 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Laryngeal Strobe 9400 by PENTAX of America, Inc. — 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 | 49613330394002H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PENTAX of America Inc.
- EUDAMED SRN
- US-MF-000008135
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED 473d1458-1d2e-4d88-8b19-107397fb37df 61 fields · synced Jul 31, 2026
- FDA UDI 9c644af6-d291-4715-9a52-ab9dc5f0e6a3 34 fields · synced May 29, 2026