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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

Ambiance Medical Skin Barrier Wipes — Class I MDR

MD Atlas
Ambiance Healthcare B.V.

EUDAMED last updated this device on Oct 2, 2023

Ambiance Medical Skin Barrier Wipes

871886817910018C

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ambiance Healthcare B.V.
UDI-DI code: 08718868179043
Reference / catalog number: 100018

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View device family (Basic UDI)

Manufacturer information

Organization name: Ambiance Healthcare B.V.
SRN: NL-MF-000035689
Manufacturer status: Active

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Ambiance Medical Adhesive Remover 30ML Spray871886817910008AOn the market Ambiance Medical Adhesive Remover 50ML Spray871886817910008AOn the market Ambiance Medical Adhesive Remover Wipes871886817910008AOn the market Ambiance Medical Skin Barrier 50ML Spray871886817910018COn 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.

Critical warnings

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

CW131
EUDAMED did not publish a description for this code.
CW133
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: Ambiance Medical Skin Barrier Wipes
UDI-DI code: 08718868179043
Basic UDI-DI: 871886817910018C
Reference / catalog number: 100018
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Ambiance Medical Skin Barrier Wipes
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)08718868179043

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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.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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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