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351/45-006 40x50cm Shield & Arm0.5mm pb Acrylic Window

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 351/45-006

by Kenex (Electro-Medical) Limited

Identity

Trade Name
351/45-006 40x50cm Shield & Arm0.5mm pb Acrylic Window EUDAMED
KENEX FDA UDI
Generic Name
Radiation shielding panel, fixed FDA UDI
Device Name
Overhead suspended radiation shields (with or without lights) EUDAMED
351/45-006 40x50cm Shield & Arm 0.5mm pb Acrylic Window FDA UDI
Model / Reference
351/45-006 EUDAMEDFDA UDI
Description
351/45-006 40x50cm Shield & Arm 0.5mm pb Acrylic Window FDA UDI

Identifiers

Catalog Number
351/45-006 FDA UDI
Primary DI / UDI-DI
05055449402026 EUDAMEDFDA UDI
Basic UDI-DI
50554494SHOXP EUDAMED
Direct Marketing DI
05055449402026 EUDAMED
FDA Product Code
EAK FDA UDI
EMDN Code
T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
GMDN Term
Radiation shielding panel, fixed FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
892.6500 FDA UDI
Market of Registration
Germany 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

Yes

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

351/45-006 40x50cm Shield & Arm0.5mm pb Acrylic Window by Kenex (electro-Medical) Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
GB-MF-000009022
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 33cf38d3-54a4-4d6b-9abb-a8b100c819b7 61 fields · synced Jul 22, 2026
  • FDA UDI d231977e-4bb6-4ab7-827b-0669852b58c0 34 fields · synced May 30, 2026