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R82

FDA UDI

Class I (US FDA UDI)

by R82 A/S

Identity

Trade Name
R82 FDA UDI
Generic Name
Assistive pushchair FDA UDI
Model / Reference
Stingray ONE-SIZE FDA UDI

Identifiers

Catalog Number
8722212 FDA UDI
Primary DI / UDI-DI
05707292598035 FDA UDI
FDA Product Code
INM FDA UDI
GMDN Term
Assistive pushchair 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: Assistive pushchair

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

Similar devices

Also classified as Assistive pushchair.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
R82 A/S

Sources (1)

  • FDA UDI f34c93f5-efcb-4c7f-9050-865ed4aa2248 33 fields · synced Jun 1, 2026