Identity
- Trade Name
- Hausted EUDAMEDFDA UDI
- Generic Name
- General examination/treatment chair, electric FDA UDI
- Device Name
- Hausted All Purpose Chair EUDAMEDEye Surgery Chair FDA UDI
- Model / Reference
- APC250ST EUDAMEDESC2EYEST EUDAMEDFDA UDI
- Description
- Eye Surgery Chair FDA UDI
Identifiers
- Primary DI / UDI-DI
- M368ESC2EYEST1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M368HAUSTEDCHAIRSWQ EUDAMED
- Direct Marketing DI
- M368ESC2EYEST1 EUDAMED
- FDA Product Code
- GBB FDA UDI
- EMDN Code
- V08020101 GENERIC USE ELECTRIC MEDICAL CHAIRS EUDAMED
- GMDN Term
- General examination/treatment chair, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 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 | ++M368HAUSTEDCHAIRSWQ | 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 47159b3c-dd30-40d6-ac8f-f4d1e52c04cd 61 fields · synced Jul 11, 2026
- FDA UDI dc72a8d1-26f4-4f5c-94df-1e8dc7a64382 34 fields · synced May 30, 2026