Identity
- Device Name
- Uterine Manipulator EUDAMED
- Model / Reference
- PS3111A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223034230 EUDAMED
- Basic UDI-DI
- B-05051223034230 EUDAMED
- EMDN Code
- K01020103 MINIMALLY INVASIVE SURGERY MANIPULATORS, SINGLE-USE EUDAMEDU0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Uterine Manipulator by Unimax Medical Systems Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051223034230 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
- EUDAMED SRN
- TW-MF-000008895
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 5980bc45-f332-472e-8e03-bcbc2765e2cc 61 fields · synced Oct 6, 2026
- EUDAMED f9ebb318-e813-4727-9f2a-e5c772c78167 61 fields · synced Oct 6, 2026