Identity
- Trade Name
- SIT 4 PLUS ER EUDAMEDOTOPRONT FDA UDI
- Generic Name
- ENT chair, electric FDA UDI
- Device Name
- ENT Treatment Chair EUDAMED
- Model / Reference
- SIT 4 EUDAMED100667 EUDAMEDSIT 4 PLUS ER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260154548407 EUDAMEDFDA UDI
- Basic UDI-DI
- 426015454SITTC202111101FR EUDAMED
- FDA Product Code
- GBB FDA UDI
- EMDN Code
- V08020101 GENERIC USE ELECTRIC MEDICAL CHAIRS EUDAMED
- GMDN Term
- ENT chair, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENT chair, electric
Otopront by Happersberger Otopront GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Happersberger Otopront GmbH
Sources (2)
- FDA UDI 8f2ee228-49a0-4e5b-9d72-d24fd3445a44 32 fields · synced Aug 2, 2026
- EUDAMED 06b3276d-1452-4bc3-88ac-0e894e4ce444 61 fields · synced Aug 2, 2026