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Advincula Delineator™
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AD750-KES35Model AD750-KES25
Identity
- Trade Name
- Advincula Delineator™ EUDAMEDAdvincula Delineator™ Uterine Manipulator with 3.5 cm Stainless Steel Koh-Effici FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- Advincula Delineator™ Uterine Manipulator EUDAMEDAdvincula Delineator™ Uterine Manipulator with 3.5 cm Stainless Steel Koh-Efficient® FDA UDI
- Model / Reference
- AD750-KES25 EUDAMEDAD750-KES35 EUDAMEDFDA UDI
- Description
- Advincula Delineator™ Uterine Manipulator with 3.5 cm Stainless Steel Koh-Efficient® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937012781 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD015sYH EUDAMED
- FDA Product Code
- HEW FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Uterine manipulator, single-use 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
Advincula Delineator™ 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 5f655b0b-c604-44a4-95b1-94bff1ef77ac 61 fields · synced Jun 9, 2026
- FDA UDI 3cf4b05f-80a9-4ef9-ba51-0f30c364379b 33 fields · synced May 30, 2026