← Back to catalogue

R82

FDA UDI

Class I (US FDA UDI)

by R82 A/S

Identity

Trade Name
R82 FDA UDI
Generic Name
Bathing stretcher FDA UDI
Model / Reference
Manatee SIZE-2 FDA UDI

Identifiers

Catalog Number
882025 FDA UDI
Primary DI / UDI-DI
05707292386915 FDA UDI
FDA Product Code
INN FDA UDI
GMDN Term
Bathing stretcher FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3100 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

Yes

FDA UDI

Category: Bathing stretcher

R82 by R82 A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bathing stretcher.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
R82 A/S

Sources (1)

  • FDA UDI c1ec60e8-5dd2-47b4-81a4-27fe5d6d3364 33 fields · synced Jun 1, 2026