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Blom-Singer® Advantage Indwelling 20 Fr. (Hard Valve) Voice Prosthesis, 4mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref AD 2004-NS
Identity
- Trade Name
- Blom-Singer® Advantage Indwelling 20 Fr. (Hard Valve) Voice Prosthesis, 4mm EUDAMEDInHealth Technologies; Blom-Singer; Advantage FDA UDI
- Generic Name
- Tracheoesophageal device introducer FDA UDI
- Device Name
- Blom-Singer® Advantage Indwelling 20 Fr. (Hard Valve) Voice Prosthesis, 4mm EUDAMED
- Model / Reference
- AD 2004-NS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813307010845 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813307010845 EUDAMED
- FDA Product Code
- EPE FDA UDIEWL FDA UDI
- EMDN Code
- P0204 LARYNX PROSTHESES EUDAMED
- GMDN Term
- Tracheoesophageal device introducer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5795 FDA UDI874.3730 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Blom-Singer® Advantage Indwelling 20 Fr. (Hard Valve) Voice Prosthesis, 4mm by Freudenberg Medical LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813307010845 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Freudenberg Medical LLC
- EUDAMED SRN
- US-MF-000023823
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 63066eeb-37bb-4f1f-a724-c3e2955a164f 61 fields · synced Jun 19, 2026
- FDA UDI bade5aa8-60eb-4cee-b1a6-2e25b3467e2b 34 fields · synced May 30, 2026