Identity
- Trade Name
- Hausted EUDAMEDFDA UDI
- Generic Name
- General examination/treatment chair, manual FDA UDI
- Device Name
- Hausted All Purpose Chair EUDAMEDMammography/Biopsy Chair FDA UDI
- Model / Reference
- APC250ST EUDAMEDMBC000ST EUDAMEDFDA UDI
- Description
- Mammography/Biopsy Chair FDA UDI
Identifiers
- Catalog Number
- MBC000ST FDA UDI
- Primary DI / UDI-DI
- M368MBC000ST1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M368HAUSTEDCHAIRSWQ EUDAMED
- Direct Marketing DI
- M368MBC000ST1 EUDAMED
- FDA Product Code
- FZK FDA UDI
- EMDN Code
- V080202 MANUAL MEDICAL CHAIRS EUDAMED
- GMDN Term
- General examination/treatment chair, manual 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 | ++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 4b267e1a-9cef-4dbc-92e3-19a12e55f7e4 61 fields · synced Jul 19, 2026
- FDA UDI aa1580a1-61c7-4f15-bb17-9067198a1bdc 35 fields · synced May 30, 2026