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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

63.00.201 — Class I MDR by Ardo medical AG

MD Atlas
Ardo medical AG

EUDAMED last updated this device on Dec 30, 2025

63.00.201

764010905nippleshieldE8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ardo medical AG
UDI-DI code: 07640109053373
Reference / catalog number: 63.00.201

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Manufacturer information

Organization name: Ardo medical AG
SRN: CH-MF-000016526
Manufacturer status: Active

Related devices

63.00.32B-07640109051768On the market 63.00.319B-07640109055872On the market 63.00.191B-07640109053274On the market 63.00.192B-07640109053281On the market 63.00.504B-07640108050885On 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

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.

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

Device identification

Trade name: not provided
UDI-DI code: 07640109053373
Basic UDI-DI: 764010905nippleshieldE8
Reference / catalog number: 63.00.201
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: TULIPS Nipple shields size L (2 pcs)
Additional information URL: https://www.ardomedical.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y090699DEVICES FOR BODY PROTECTION - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification