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Organization name
UDI-DI code
Reference / catalog number

00015152 — Class IIa MDD by HOFFRICHTER GmbH

MD Atlas
HOFFRICHTER GmbH

EUDAMED last updated this device on May 17, 2024

00015152

B-04250316301889

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: HOFFRICHTER GmbH
UDI-DI code: 04250316301889
Reference / catalog number: 00015152

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Manufacturer information

Organization name: HOFFRICHTER GmbH
SRN: DE-MF-000004928
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.
CW999
Risk of injury due to contraindications! Respiratory therapy may be contraindicated for certain pre-existing conditions. These pre-existing conditions include: • Bullous lung disease • Pneumothorax • Very low blood pressure • Air accumulation following an open traumatic brain injury or other head injuries In case of a sinus infection or an infection of the middle ear, the doctor must verify that therapy may continue.
CW011
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	Mar 7, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04250316301889
Basic UDI-DI: B-04250316301889
Reference / catalog number: 00015152
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The device "TREND III" is used for non-invasive pressure-controlled breathing support. The device is suitable for the treatment of obstructive sleep apnea in patients over 30 kg, especially when required by higher pressures and / or forms of respiratory failure. Therapy pressure is administered via a breathing mask, which must be equipped with a passive exhalation valve to ensure exhalation air discharge. Use of the device is intended for home medical care and professional health care facilities such as sleep laboratories and hospitals.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030102CONTINUOUS POSITIVE PRESSURE 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

00015037B-04250316301445On the market 00002073B-04250316300677On the market 00013039B-04250316301414On the market 00013135B-04250316301964On the market 00013040B-04250316301421On 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.