Identity
- Trade Name
- DuoRipe™ EUDAMED
- Device Name
- DuoRipe™Cervical Ripening Balloon EUDAMED
- Model / Reference
- J-CRB-184000 EUDAMEDJ-CRBS-184000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00888937027877 EUDAMED00888937027860 EUDAMED
- Basic UDI-DI
- 0888937TD131ZK EUDAMED
- EMDN Code
- U1099 OBSTETRICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
DuoRipe™ by CooperSurgical, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0888937TD131ZK | Class IIa | 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 f2504ec7-2aa3-49e3-9e29-0708a8894520 61 fields · synced Jul 10, 2026
- EUDAMED dfe3d7a2-ce2b-4d24-ab7d-72cb8786359b 61 fields · synced May 18, 2026