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Organization name
UDI-DI code
Reference / catalog number

HICO-Variotherm 550 — Class IIb MDR by pfm medical hico GmbH

MD Atlas
pfm medical hico GmbH

EUDAMED last updated this device on Jun 4, 2024

HICO-Variotherm 550

4042301Z1204AAVT

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: pfm medical hico GmbH
UDI-DI code: 04042301205797
Reference / catalog number: 540001

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Manufacturer information

Organization name: pfm medical hico GmbH
SRN: DE-MF-000012921
Manufacturer status: Active

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 Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 1, 2023	Still on market

Device identification

Trade name: HICO-Variotherm 550
UDI-DI code: 04042301205797
Basic UDI-DI: 4042301Z1204AAVT
Reference / catalog number: 540001
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040208BODY THERMOREGULATION 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

Certificate health across this manufacturer's portfolio.

FI24/00000026Amended
Quality management systemNotified body: 0598Expiry: Apr 17, 2029