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RUMI® II Koh-Efficient™
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref KC-RUMI-30Model AD750-KES25
Identity
- Trade Name
- RUMI® II Koh-Efficient™ EUDAMEDRUMI II Koh-Efficient FDA UDI
- Generic Name
- Colpotomy tube FDA UDI
- Device Name
- Advincula Delineator™ Uterine Manipulator EUDAMEDRUMI II Koh-Efficient- 3.0 cm for use with the RUMI II Handle FDA UDI
- Model / Reference
- AD750-KES25 EUDAMEDKC-RUMI-30 EUDAMEDFDA UDI
- Description
- RUMI II Koh-Efficient- 3.0 cm for use with the RUMI II Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015072 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD015sYH EUDAMED
- FDA Product Code
- HEW FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Colpotomy tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1640 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
RUMI® II Koh-Efficient™ 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 | 0888937TD015sYH | 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 562b455a-fee9-43fa-afbc-117bc54834dd 61 fields · synced Jul 8, 2026
- FDA UDI 0a7cae82-cbcd-43b6-a577-4efbfcacd5e1 34 fields · synced May 29, 2026