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

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Organization name
UDI-DI code
Reference / catalog number

CH8 OP L — Class I MDR by GRAPHITE MEDICAL

MD Atlas
GRAPHITE MEDICAL

EUDAMED last updated this device on Apr 16, 2026

CH8 OP L

36156CH8FA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GRAPHITE MEDICAL
UDI-DI code: 03615650003782
Reference / catalog number: CH8 OP L

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Manufacturer information

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

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03615650003782
Basic UDI-DI: 36156CH8FA
Reference / catalog number: CH8 OP L
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: Ankle brace CH8 posterior opening size L
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y06120601PASSIVE ANKLE-FOOT 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

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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.