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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

PKDEMOSAC01 — Class I MDR by SYSTEM ASSISTANCE MEDICAL

MD Atlas
SYSTEM ASSISTANCE MEDICAL

EUDAMED last updated this device on Dec 24, 2025

PKDEMOSAC01

37003686PKDEMOSAC011H3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SYSTEM ASSISTANCE MEDICAL
UDI-DI code: 03700368616901
Reference / catalog number: PKDEMOSAC01

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Manufacturer information

Organization name: SYSTEM ASSISTANCE MEDICAL
SRN: FR-MF-000003517
Manufacturer status: Active

Related devices

SYST'AM P111MPPMHI37003686P111MHI1Z7On the market P301C40431HW37003686P301CHW1YYOn the market P301C43431HW37003686P301CHW1YYOn the market P301C46461HW37003686P301CHW1YYOn the market P302C43431HW37003686P302CHW1ZBOn 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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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: 03700368616901
Basic UDI-DI: 37003686PKDEMOSAC011H3
Reference / catalog number: PKDEMOSAC01
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: SYST'AM TRANSPORT BAG
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0399PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - 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
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Software identification