Ardo Melia 63.00.571

GUDID 07640108054982

Wearable double electric breastpump

Ardo medical AG

Breast pump, electric

• Primary Device ID: 07640108054982
• NIH Device Record Key: 94fdf19f-3f2c-44c3-88ee-615db4650b33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ardo Melia
• Version Model Number: 63.00.571
• Catalog Number: 63.00.571
• Company DUNS: 481670396
• Company Name: Ardo medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640108054975 [Primary]
GS1	07640108054982 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242850

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-09
• Device Publish Date: 2026-02-27

Devices Manufactured by Ardo medical AG

• 07640108054982 - Ardo Melia: 2026-03-09Wearable double electric breastpump
• 07640108054982 - Ardo Melia: 2026-03-09 Wearable double electric breastpump
• 07640108051080 - Alyssa Hands-Free to-go: 2025-09-23
• 07640108055507 - Hospital Kit DeTach 21 mm: 2025-09-04 The Hospital Kit should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an
• 07640108055521 - Hospital Kit DeTach 24 mm: 2025-09-04 The Hospital Kit should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an
• 07640108052506 - Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit Fussschalter: 2025-07-24
• 07640108053374 - Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V: 2025-07-24
• 07640108055293 - Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115V: 2025-07-24
• 07640108054470 - Alyssa Hands-Free: 2024-01-30 Breast Pump, electric, with hands-free-pumpset