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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

660300 — Class IIa MDR by The Surgical Company…

MD Atlas
The Surgical Company International B.V.

EUDAMED last updated this device on Mar 26, 2026

660300

8719867EMDNZ12030380PCK4

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: The Surgical Company International B.V.
UDI-DI code: 18719867001622
Reference / catalog number: 660300

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View device family (Basic UDI)

Manufacturer information

Organization name: The Surgical Company International B.V.
SRN: NL-MF-000001973
Manufacturer status: Active

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6604008719867EMDNZ12030380AGHXOn the market 650100B-18719867001554On the market 6607008719867EMDNV0899FCHJMOn the market 672000B-18719867001776On the market 650200B-18719867001561On the market

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 18719867001622
Basic UDI-DI: 8719867EMDNZ12030380PCK4
Reference / catalog number: 660300
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The Fluido® Pressure Chambers can pressurize smal (500 ml) and large (1000 ml) IV fluid or standardized (ISO 15747:2019) blood bags used with the Blood and Fluid Warmer System. The module consists of a dual chamber configuration with a common pressure regulator and individual pressure gauges (manometers). The air required to pressurize the chambers is supplied by the Fluido® Compressor.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)18719867001622

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12030380INFUSION INSTRUMENTS - HARDWARE ACCESSORIES

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

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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.