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Manatee

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 882005Model Toilet & Bath

by R82 A/S

Identity

Trade Name
Manatee EUDAMED
R82 FDA UDI
Generic Name
Bathing stretcher FDA UDI
Model / Reference
Toilet & Bath EUDAMED
882005 EUDAMED
Manatee SIZE-0 FDA UDI

Identifiers

Catalog Number
882005 FDA UDI
Primary DI / UDI-DI
05707292416704 EUDAMEDFDA UDI
Basic UDI-DI
57072920933074F EUDAMED
FDA Product Code
INN FDA UDI
EMDN Code
Y1299 PERSONAL MOBILITY DEVICES - OTHER EUDAMED
GMDN Term
Bathing stretcher FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
890.3100 FDA UDI
Market of Registration
Denmark EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
R82 A/S
EUDAMED SRN
DK-MF-000000772

Sources (2)

  • EUDAMED 00618745-1ffd-49b7-8d9c-78c5c2a94016 61 fields · synced Jun 18, 2026
  • FDA UDI f416510a-9a48-4027-a9ef-ba463d6ccbe6 33 fields · synced May 30, 2026