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Spackman Uterine Manipulator/Injector
EUDAMEDClass I (EU MDR)
Ref PS3112Model TF-1003
Identity
- Trade Name
- Spackman Uterine Manipulator/Injector EUDAMED
- Device Name
- Spackman Uterine Manipulator/Injector EUDAMED
- Model / Reference
- TF-1003 EUDAMEDPS3112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223003748 EUDAMED
- Basic UDI-DI
- B-05051223003748 EUDAMED
- EMDN Code
- U080199 GYNAECOLOGICAL CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Spackman Uterine Manipulator/Injector by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and…
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-05051223003748 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 366ab92e-5036-4546-a48d-0e5402017b0c 61 fields · synced Oct 5, 2026