Identity
- Trade Name
- Hausted EUDAMEDFDA UDI
- Generic Name
- Operating room stool FDA UDI
- Device Name
- Surgeon Stool EUDAMEDHausted Surgeon Stool, Saddle Seat FDA UDI
- Model / Reference
- HSS500-S EUDAMEDFDA UDI
- Description
- Hausted Surgeon Stool, Saddle Seat FDA UDI
Identifiers
- Catalog Number
- HSS500-S FDA UDI
- Primary DI / UDI-DI
- M368HSS500S1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M368SURGICALSTOOLPD EUDAMED
- Direct Marketing DI
- M368HSS500S1 EUDAMED
- FDA Product Code
- FZM FDA UDI
- EMDN Code
- Z12011201 OPERATING CHAIRS EUDAMED
- GMDN Term
- Operating room stool FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Netherlands 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
No
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
Hausted by GF Health Products, 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 | ++M368SURGICALSTOOLPD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GF Health Products, Inc.
- EUDAMED SRN
- US-MF-000002167
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED bac28130-e09e-4bb0-8485-60d00c599f67 61 fields · synced Jul 15, 2026
- FDA UDI 5f58de00-ff9b-4fe7-8be7-39bfa0ed3c98 34 fields · synced May 30, 2026