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Tulips

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 63.00.23

by Ardo medical AG

Identity

Trade Name
TULIPS EUDAMED
Tulips Size S FDA UDI
Generic Name
Nipple shielding teat, reusable FDA UDI
Device Name
Tulips EUDAMED
Nipple Shields Size S FDA UDI
Model / Reference
63.00.23 EUDAMEDFDA UDI
Description
Nipple Shields Size S FDA UDI

Identifiers

Catalog Number
63.00.23 FDA UDI
Primary DI / UDI-DI
07640109055902 EUDAMED
00814079021862 FDA UDI
Basic UDI-DI
B-07640109055902 EUDAMED
FDA Product Code
HFS FDA UDI
EMDN Code
Y090699 DEVICES FOR BODY PROTECTION - OTHER EUDAMED
GMDN Term
Nipple shielding teat, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
880.5630 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Tulips by Ardo medical AG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ardo medical AG
EUDAMED SRN
CH-MF-000016526
Authorised Representative
ARDO medical GmbH DE-AR-000014440

Sources (2)

  • EUDAMED 7e5046e0-2509-42fc-894c-4768d5d5cfc8 61 fields · synced Jul 24, 2026
  • FDA UDI 161d8a13-512e-441f-b9ef-291dd73cb8ff 35 fields · synced May 29, 2026