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ALLY II UPS™ (Uterine Positioning System)
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref LAU-INT2Model AU-INT2
Identity
- Trade Name
- ALLY II UPS™ (Uterine Positioning System) EUDAMED
- Device Name
- ALLY II UPS™ (Uterine Positioning System) EUDAMED
- Model / Reference
- AU-INT2 EUDAMEDLAU-INT2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00888937027754 EUDAMED
- Basic UDI-DI
- 0888937TD003Z9 EUDAMED
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
ALLY II UPS™ (Uterine Positioning System) by CooperSurgical, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153092 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0888937TD003Z9 | Class I | Active |
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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 d54bdb5f-8517-478f-b0e2-7a44a141a572 61 fields · synced Jun 18, 2026
- FDA 510(k) K153092 1 fields · synced May 18, 2026