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Organization name
UDI-DI code
Reference / catalog number

HS-RH-XL-LI — Class I MDR by iMEDgine GmbH

MD Atlas
iMEDgine GmbH

EUDAMED last updated this device on Oct 17, 2022

HS-RH-XL-LI

PP1198101.01.0163

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: iMEDgine GmbH
UDI-DI code: 1111782596345
Reference / catalog number: HS-RH-XL-LI

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Manufacturer information

Organization name: iMEDgine GmbH
SRN: DE-MF-000019865
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Aug 16, 2022	Still on market
Austria	Aug 16, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 1111782596345
Basic UDI-DI: PP1198101.01.0163
Reference / catalog number: HS-RH-XL-LI
Issuing entity: IFA

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: handscupe rheumatism, links, Größe XL
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: XL

EMDN nomenclature code(s)

Y241899ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

HS-RH-L-REPP1198101.01.0163On the market HS-RH-S-REPP1198101.01.0163On the market XXS/XS/S/M/L/XL-F/C-RE/LI-1121-00426253722Handscupes!YDOn the market L-4121-00-PAPP1198101.01.0279On the market M-3121-00-PAPP1198101.01.0279On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.