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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

COMPRS04 — Class IIb MDD by Biosurgical S.L

MD Atlas
Biosurgical S.L

EUDAMED last updated this device on Nov 5, 2022

COMPRS04

B-05065011188111

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Biosurgical S.L
UDI-DI code: 05065011188111
Reference / catalog number: COMPRS04

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Manufacturer information

Organization name: Biosurgical S.L
SRN: ES-MF-000008631
Manufacturer status: Active

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW010
Use exclusively with PRS disposable kits and accessories. The use of any other disposable kits or accessories could damage the equipment, and/or harm the patient
CW016
Description /Electrical Risk
CW024
This device is sensible to proximity of electromagnetic fields according to ruleIECE6061-1-2. Components are protected by the device cases and at a minimum distance of 15 cm as exception applied
CW273
Danger of electric shock. Do not open the system
CW011
To avoid the risk of electric shock, this system should only be connected to a power supply grid with grounding protection

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05065011188111
Basic UDI-DI: B-05065011188111
Reference / catalog number: COMPRS04
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: RECIRCULATION SYSTEMS FORWARMING THERAPEUTIC FLUIDS
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

Related devices

BIOPRSC1222V3/PRSKIT03B-05065011188401On the market COMPRS03B-05065011188104On the market PRSTEMPB-05065011188302On 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.