Identity
- Trade Name
- Silicone Birth Vac Cup EUDAMEDFDA UDI
- Generic Name
- Foetal vacuum extraction system cup, reusable FDA UDI
- Device Name
- Silicone Birth Vac Cup EUDAMED
- Model / Reference
- 1300-0050 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711182604004 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711182604004 EUDAMED
- 510(k) Number
- K021193 FDA UDI
- FDA Product Code
- HDB FDA UDI
- EMDN Code
- Z12080301 OBSTETRIC VACUUM EXTRACTORS EUDAMED
- GMDN Term
- Foetal vacuum extraction system cup, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4340 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foetal vacuum extraction system cup, single-use
Silicone Birth Vac Cup by Fortune Medical Instrument Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04711182604004 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED df2c6f70-fe6f-4b80-a4ec-5665af17cde7 61 fields · synced Jun 19, 2026
- FDA UDI 105ca7c6-fe44-4674-941b-d14cf83b3692 33 fields · synced May 29, 2026