Hct
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- 119123J052050 EUDAMEDHCT FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- rollator EUDAMED
- Model / Reference
- HCT-9123 EUDAMEDFDA UDIHCT-9166A,HCT-9166B,HCT-9266A,HCT-9102B,HCT-9102D,HCT-9189,HCT-9102E,HCT-9226S,HCT-9137,HCT-9137A,HCT-9124,HCT-9124A,HCT-9188,HCT-9188B,HCT-9123,HCT-9210A,HCT-9210C,HCT-9201A,HCT-9201B,HCT-9201C,HCT-9201E,HCT-9291,HCT-9291B,HCT-9291C,HCT-9291D,...etc EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973536540781 EUDAMED06973536540002 FDA UDI
- Basic UDI-DI
- 697353654rollator001XL EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
- GMDN Term
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3825 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Handgrip disability-assistive walker, non-powered, foldable
Hct by Foshan HCT Medical Equipment Co., ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Handgrip disability-assistive walker, non-powered, foldable.
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- Drive — Drive Devilbiss Healthcare · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foshan HCT Medical Equipment Co., ltd
Sources (2)
- FDA UDI fa8e3fde-374b-4813-a152-002f39949489 32 fields · synced Jul 12, 2026
- EUDAMED 0f2b36f2-4462-446a-ae49-4bb688b91fa7 61 fields · synced Jul 12, 2026