Applicator Clamp Holder
FDA UDIEUDAMEDClass II (US FDA UDI)
by Qfix
Identity
- Trade Name
- Applicator Clamp Holder FDA UDI
- Generic Name
- Patient lifting system stretcher FDA UDI
- Device Name
- Applicator Clamp Holder, Rail Mounted FDA UDI
- Model / Reference
- RT-5100-52 EUDAMEDFDA UDIPatient Transport EUDAMED
- Description
- Applicator Clamp Holder, Rail Mounted FDA UDI
Identifiers
- Catalog Number
- RT-5100-52 FDA UDI
- Primary DI / UDI-DI
- 10841962119402 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621PTTRANSPORTT7 EUDAMED
- 510(k) Number
- K160627 FDA UDI
- FDA Product Code
- JAK FDA UDIIYE FDA UDIKPS FDA UDIJAI FDA UDILNH FDA UDIFRZ FDA UDIOUO FDA UDILHN FDA UDI
- EMDN Code
- V080504 PATIENT TRANSFER BOARDS AND TABLES EUDAMED
- GMDN Term
- Patient lifting system stretcher FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI892.5050 FDA UDI892.1200 FDA UDI892.5770 FDA UDI892.1000 FDA UDI880.6775 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Patient lifting system stretcher
Applicator Clamp Holder by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient lifting system stretcher.
- Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I
- Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I
- Trans — Invacare GmbH · Class I
- Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I
- Transfer board — Mobilex A/S · Class I
- Powered Loading System (PLS) (Component) — LIFEPORT, LLC. · Class I
- INSTALLATION, POWER LOADING SYSTEM, CESSNA 680 * PLS — LIFEPORT, LLC. · Class I
- Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I
Cleared under the same submission
K160627 also covers:
- AirDrive Trolley™ — Qfix
- AirShuttle Locating Bar — Qfix
- AirShuttle Locating Bar — Qfix
- AirShuttle Transfer Handle — Qfix
- AirShuttle Transfer Handle — Qfix
- Applicator Clamp Holder — Qfix
- Edge Guide System — Qfix
- InfinityLock™ — Qfix
- Leg Extension — Qfix
- Leg Extension — Qfix
- Leg Extension — Qfix
- Symphony™ — Qfix
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 3b56ef98-eb7a-498e-bd75-65cea3b32e90 36 fields · synced Jul 14, 2026
- EUDAMED de595d6c-e238-43e2-a749-52452729e00e 61 fields · synced Jul 14, 2026