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Handicare

FDA UDI

Class I (US FDA UDI)

by Handicare Usa, Inc.

Identity

Trade Name
Handicare FDA UDI
Generic Name
General-purpose patient lifting system sling/harness FDA UDI
Device Name
Comfort Care Spacer H/S - XXS FDA UDI
Model / Reference
8E4730 FDA UDI
Description
Comfort Care Spacer H/S - XXS FDA UDI

Identifiers

Primary DI / UDI-DI
00810045515977 FDA UDI
FDA Product Code
INE FDA UDI
GMDN Term
General-purpose patient lifting system sling/harness FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

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

Category: General-purpose patient lifting system sling/harness

Handicare by Handicare Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose patient lifting system sling/harness.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Handicare Usa, Inc.

Sources (1)

  • FDA UDI 7c3c95f5-b162-4941-9b17-c1d07a15a747 33 fields · synced Jun 1, 2026