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Classic Pro Folder (88cm) 35in
EUDAMEDFDA UDIClass I (EU MDR)
Ref HA6126Model REACHER
Identity
- Trade Name
- CLASSIC PRO FOLDER (88CM) 35IN EUDAMEDREACHER FDA UDI
- Generic Name
- Assistive manual gripping tongs FDA UDI
- Device Name
- TIDY JON 18IN (45CM) RED EUDAMEDREACHER FDA UDI
- Model / Reference
- REACHER EUDAMEDHA6126 EUDAMEDCLASSIC PRO FOLDER 35IN FDA UDI
- Description
- REACHER FDA UDI
Identifiers
- Catalog Number
- HA6432 FDA UDI
- Primary DI / UDI-DI
- 05050962156258 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050962REACHERSVG EUDAMED
- FDA Product Code
- ILD FDA UDI
- EMDN Code
- Y242103 MANUAL PREHENSILE GRIPPERS EUDAMED
- GMDN Term
- Assistive manual gripping tongs FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Classic Pro Folder (88cm) 35in 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 | 5050962REACHERSVG | 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 77e153fd-c22b-40d3-b2ca-15d41ec5dc57 61 fields · synced Oct 5, 2026
- FDA UDI 09815c31-4bcd-4360-bbc8-8a4d34352264 35 fields · synced May 30, 2026