Identity
- Trade Name
- Blom-Singer FDA UDI
- Generic Name
- Transcervical artificial larynx FDA UDI
- Device Name
- ElectroLarynx EUDAMEDElectrolarynx Oral Adapter FDA UDI
- Model / Reference
- EL 1002 EUDAMEDFDA UDI
- Description
- Electrolarynx Oral Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850057368021 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850057368ElectroLarynxD2 EUDAMED
- FDA Product Code
- ESE FDA UDI
- EMDN Code
- Y214212 VOICE GENERATORS EUDAMED
- GMDN Term
- Transcervical artificial larynx FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.3375 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ElectroLarynx by ENT Solutions LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850057368ElectroLarynxD2 | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ENT Solutions LLC
- EUDAMED SRN
- US-MF-000037670
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (2)
- EUDAMED 095e2afd-28bd-4a22-bec3-9d6d5f3749d2 61 fields · synced Jul 25, 2026
- FDA UDI 790bd0f4-6b4c-400f-815c-f7170c4b4e53 34 fields · synced May 29, 2026