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

H2 XXL — Class I MDR by GRAPHITE MEDICAL

MD Atlas
GRAPHITE MEDICAL

EUDAMED last updated this device on Mar 9, 2026

H2 XXL

36156H22D

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GRAPHITE MEDICAL
UDI-DI code: 03615650002624
Reference / catalog number: H2 XXL

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: GRAPHITE MEDICAL
SRN: FR-MF-000002504
Manufacturer status: Active

Related devices

GH1 60 L36156GH1FGOn the market ABDO 18 S NOI36156ABDOWWOn the market ABDO 31 XL36156ABDOWWOn the market ABDO 18 L NOI36156ABDOWWOn the market ABDO 18 L36156ABDOWWOn the market

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 03615650002624
Basic UDI-DI: 36156H22D
Reference / catalog number: H2 XXL
Issuing entity: GS1

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: Ventilated shoulder immobilizer H2 size XXL
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060624SHOULDER-ELBOW ORTHOSES

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

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.