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Tulips
EUDAMEDFDA UDIClass I (EU MDR)
Ref 63.00.201Ref 63.00.202Ref 63.00.285Ref 63.00.205
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
- 63.00.201 EUDAMEDFDA UDI63.00.202 EUDAMED63.00.285 EUDAMED63.00.205 EUDAMED
- Description
- Nipple Shields Size L FDA UDI
Identifiers
- Catalog Number
- 63.00.201 FDA UDI
- Primary DI / UDI-DI
- 07640109053373 EUDAMED07640109053380 EUDAMED07640108050113 EUDAMED07640109053410 EUDAMED00814079020186 FDA UDI
- Basic UDI-DI
- 764010905nippleshieldE8 EUDAMEDB-07640109053380 EUDAMEDB-07640108050113 EUDAMEDB-07640109053410 EUDAMED
- Direct Marketing DI
- 07640109053373 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 I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 880.5630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMED
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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 I — 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 | 764010905nippleshieldE8 | Class I | Active |
| EUDAMED | European Union | CE/MDD | 764010905nippleshieldE8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (5)
- EUDAMED 18cc6c04-d18a-4926-aefe-947072cf7996 61 fields · synced Jul 30, 2026
- EUDAMED f7e538a6-c0b3-40eb-8619-0aeeb29d993a 61 fields · synced May 17, 2026
- EUDAMED 3a32b7f5-2feb-40d7-9ceb-f375acd547d4 61 fields · synced May 17, 2026
- EUDAMED 5db6552c-fc72-4d34-90be-38ba8171dfb1 61 fields · synced May 19, 2026
- FDA UDI dc1aa1b9-3ad9-4544-b627-27973487839b 35 fields · synced May 30, 2026