Identity
- Trade Name
- SMALL TILTRITE MANUAL STANDARD EUDAMEDSMALL TILTRITE FDA UDI
- Generic Name
- General examination/treatment chair, electric FDA UDI
- Device Name
- SMALL TILTRITE CHAIR EUDAMEDSMALL TILTRITE FDA UDI
- Model / Reference
- STMST EUDAMEDMANUAL STANDARD BACK FDA UDI
- Description
- SMALL TILTRITE FDA UDI
Identifiers
- Catalog Number
- STMST FDA UDI
- Primary DI / UDI-DI
- 05050962011670 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050962SMALLTILTLJ EUDAMED
- Direct Marketing DI
- 05050962011670 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- V080202 MANUAL MEDICAL CHAIRS EUDAMED
- GMDN Term
- General examination/treatment chair, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Northern Ireland 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
Yes
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
Small Tiltrite Manual Standard by Helping Hand Company (Ledbury) Ltd — 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 | 5050962SMALLTILTLJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Helping Hand Company (Ledbury) Ltd
- EUDAMED SRN
- GB-MF-000011951
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (2)
- EUDAMED 20cfbdc9-531b-4183-8b3c-ec45381b6ecf 61 fields · synced Oct 6, 2026
- FDA UDI d5cc65b0-5be0-411f-91d6-998d3a468be1 35 fields · synced May 29, 2026