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Neotech Bridge®
EUDAMEDFDA UDIClass I (EU MDR)
Ref N8001-30Model Neotech Bridge®
Identity
- Trade Name
- Neotech Bridge® EUDAMEDFDA UDI
- Generic Name
- Breast pump support kit, reusable FDA UDI
- Device Name
- Neotech Bridge® EUDAMEDThe Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest FDA UDI
- Model / Reference
- Neotech Bridge® EUDAMEDN8001-30 EUDAMEDBridge Only - 30pcs FDA UDI
- Description
- The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest FDA UDI
Identifiers
- Catalog Number
- N8001-30 FDA UDI
- Primary DI / UDI-DI
- 20812594012604 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N80010M5 EUDAMED
- FDA Product Code
- HGY FDA UDI
- EMDN Code
- V020301 MANUAL BREAST PUMPERS AND KITS EUDAMED
- GMDN Term
- Breast pump support kit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.5150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Neotech Bridge® by Neotech Products LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081259401N80010M5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f21d77ec-ddf4-4cc0-a5ab-4ef2b754d84a 61 fields · synced Jul 13, 2026
- FDA UDI 12879c01-346a-4b51-86a5-44f51ab16309 34 fields · synced May 29, 2026