Identity
- Trade Name
- TULIPS EUDAMEDTulips Size L FDA UDI
- Generic Name
- Nipple shielding teat, reusable FDA UDI
- Device Name
- Tulips EUDAMEDNipple Shields Size L FDA UDI
- Model / Reference
- 63.00.16 EUDAMEDFDA UDI
- Description
- Nipple Shields Size L FDA UDI
Identifiers
- Catalog Number
- 63.00.16 FDA UDI
- Primary DI / UDI-DI
- 07640109054035 EUDAMED00814079020728 FDA UDI
- Basic UDI-DI
- B-07640109054035 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 EUDAMEDClass 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Tulips by Ardo medical AG — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07640109054035 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640109054035 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 11b130db-e247-4fec-b682-ed21ca6700eb 61 fields · synced Jul 11, 2026
- FDA UDI e570b986-c441-4929-8644-9052d3fc0bf5 35 fields · synced May 25, 2026