Identity
- Trade Name
- SIT 4 EUDAMEDOTOPRONT FDA UDI
- Generic Name
- ENT chair, electric FDA UDI
- Device Name
- ENT Treatment Chair EUDAMED
- Model / Reference
- SIT 4 EUDAMEDFDA UDI100666 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260154548100 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
Similar devices
Also classified as ENT chair, electric.
- JEDMED — JEDMED Instrument Company · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Optomic — OPTOMIC ESPAÑA SA · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Happersberger Otopront GmbH
Sources (2)
- FDA UDI 02a083d0-5bb1-4946-b5fd-deff0eeeb954 32 fields · synced Jul 10, 2026
- EUDAMED c58e4764-3525-44ca-95b8-07974ae1050a 61 fields · synced Jul 10, 2026