Identity
- Trade Name
- Lumex EUDAMEDFDA UDI
- Generic Name
- Reclining chair FDA UDI
- Device Name
- Clinical Care Recliners EUDAMEDRECLINER CL CARE FENCE FDA UDI
- Model / Reference
- FR577RG1311 EUDAMEDFDA UDI
- Description
- RECLINER CL CARE FENCE FDA UDI
Identifiers
- Catalog Number
- FR577RG1311 FDA UDI
- Primary DI / UDI-DI
- M368FR577RG13111 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M368CLINICALRECLINER2P EUDAMED
- Direct Marketing DI
- M368FR577RG13111 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- V080202 MANUAL MEDICAL CHAIRS EUDAMED
- GMDN Term
- Reclining chair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 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
Lumex 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 | ++M368CLINICALRECLINER2P | 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
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED c57aafb0-ffa3-47f1-b3e7-e8dce16aa448 61 fields · synced Aug 3, 2026
- FDA UDI 6b64d83c-c01a-4d1e-9f42-3e7e7eae3967 35 fields · synced May 30, 2026