High Easy Poly Looped Hip Tapes LOOPS Small
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- High Easy Poly Looped Hip Tapes LOOPS Small FDA UDI
- Generic Name
- General-purpose patient lifting system sling/harness FDA UDI
- Device Name
- Patient Lifting Slings EUDAMED
- Model / Reference
- M921514-S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056387416410 EUDAMEDFDA UDI
- Basic UDI-DI
- 506040783LiftingSlings33 EUDAMED
- Direct Marketing DI
- 05056387416410 EUDAMED
- FDA Product Code
- INE FDA UDI
- EMDN Code
- V0805038002 NON-RIGID SUPPORTS FOR LIFTS (HARNESSES) EUDAMED
- GMDN Term
- General-purpose patient lifting system sling/harness FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 FDA UDI
- Market of Registration
- Austria 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
Yes
Category: General-purpose patient lifting system sling/harness
High Easy Poly Looped Hip Tapes LOOPS Small by Silvalea Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose patient lifting system sling/harness.
- Handicare — HANDICARE USA, INC. · Class I
- Handicare — HANDICARE USA, INC. · Class I
- Apex Lifts — Joerns Healthcare · Class I
- Long Seat - Tollos — 1073849 Ontario Limited · Class I
- Slings — Joerns Healthcare · Class I
- Accessories — Joerns Healthcare · Class I
- EZ Way — EZ Way, Inc. · Class I
- Sage TAP LC — SAGE PRODUCTS LLC · 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
- Silvalea Limited
Sources (2)
- FDA UDI f7638286-8809-4a46-8791-eda67cfad2c2 32 fields · synced Jun 19, 2026
- EUDAMED 65d3d0cc-fe0b-458a-b522-a76f0f75620a 61 fields · synced Jun 19, 2026