MityOne® Pump with M-Style®
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- MityOne® Pump with M-Style® EUDAMEDMityOne FDA UDI
- Generic Name
- Foetal vacuum extraction system cup, single-use FDA UDI
- Device Name
- Mityvac® M-Style® Mushroom® Cup Vacuum-Assist Delivery System EUDAMEDPump with MitySoft Bell Cup FDA UDI
- Model / Reference
- Mushroom® Cup - Vacuum-Assist Delivery System EUDAMED10068 EUDAMEDFDA UDI
- Description
- Pump with MitySoft Bell Cup FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937003130 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD07627 EUDAMED
- 510(k) Number
- K890307 FDA UDI
- FDA Product Code
- HDB FDA UDI
- EMDN Code
- Z12080301 OBSTETRIC VACUUM EXTRACTORS EUDAMED
- GMDN Term
- Foetal vacuum extraction system cup, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4340 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Foetal vacuum extraction system cup, single-use
MityOne® Pump with M-Style® by CooperSurgical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0888937TD07627 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (2)
- EUDAMED 7244af98-77f4-4402-b4eb-7480e06f5a7f 61 fields · synced Jul 25, 2026
- FDA UDI a6a2566e-0cf7-497e-b416-81f6c6aaa2ef 34 fields · synced May 30, 2026