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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

71_08_000 — Class IIb MDR by GAMIDA TECH

MD Atlas
GAMIDA TECH

EUDAMED last updated this device on Oct 21, 2025

71_08_000

37003704SunChip254

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GAMIDA TECH
UDI-DI code: 03700370400901
Reference / catalog number: 71_08_000

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Manufacturer information

Organization name: GAMIDA TECH
SRN: FR-MF-000009097
Manufacturer status: Active

Critical warnings

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

CW010
Warnings and contra-indications are described in IFU

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Sep 26, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03700370400901
Basic UDI-DI: 37003704SunChip254
Reference / catalog number: 71_08_000
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The SunChip 2 is an equipment used for the medical administration of chemotherapy substances as part of a hyperthermic chemotherapy procedure, in patients' peritoneal (HIPEC) or thoracic (HITEC) cavities, using an open or closed technique. It is used with dedicated single-use sterile medical devices.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1204021501MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT

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.