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Disposable Uterine Manipulator
EUDAMEDClass IIa (EU MDR)
Ref F21404Ref F21402Ref F21403Ref F21401
Identity
- Device Name
- Disposable Uterine Manipulator EUDAMED
- Model / Reference
- F21404 EUDAMEDF21402 EUDAMEDF21403 EUDAMEDF21401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937893903177 EUDAMED06937893903115 EUDAMED06937893903146 EUDAMED06937893903085 EUDAMED
- Basic UDI-DI
- 69378939F2162 EUDAMED
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Disposable Uterine Manipulator by Tonglu Qianyan Medtech Co., Ltd — 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 | 69378939F2162 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tonglu Qianyan Medtech Co., Ltd
- EUDAMED SRN
- CN-MF-000017342
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (4)
- EUDAMED 66972d7a-3cf6-4635-89f8-a211d132157b 61 fields · synced Jul 29, 2026
- EUDAMED 02a5a8db-f87f-45ae-8a2c-949461e03ff5 61 fields · synced May 16, 2026
- EUDAMED f40d17fa-5905-4d2d-b12e-fc1e6b178f81 61 fields · synced May 16, 2026
- EUDAMED 9952e796-1362-4add-b6b0-793eb5e4796b 61 fields · synced May 16, 2026