Identity
- Trade Name
- RUMI® II EUDAMEDRUMI II Reusable Uterine Manipulator Handle FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- Ultem Koh Cup EUDAMEDRUMI II Reusable Uterine Manipulator Handle FDA UDI
- Model / Reference
- Ultem Koh Cup EUDAMEDUMH650 EUDAMEDFDA UDI
- Description
- RUMI II Reusable Uterine Manipulator Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015232 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD015rYF EUDAMED
- FDA Product Code
- LKF FDA UDI
- EMDN Code
- L059004 UTERINE MANIPULATORS, REUSABLE EUDAMED
- GMDN Term
- Uterine manipulator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Netherlands 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
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Rumi® Ii by CooperSurgical, Inc. — Class IIa — 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 | 0888937TD015rYF | 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 b04339f3-6343-4162-a94b-1f7b4e31eeac 61 fields · synced Jul 10, 2026
- FDA UDI 89ce3417-a7d4-4ac4-8687-aa6e9c6497bc 33 fields · synced May 29, 2026