Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

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

MD Atlas
iMEDgine GmbH

EUDAMED last updated this device on Oct 17, 2022

HS-RH-L-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: 1111782595779
Reference / catalog number: HS-RH-L-LI

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: 1111782595779
Basic UDI-DI: PP1198101.01.0163
Reference / catalog number: HS-RH-L-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 L
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: L

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.