← Back to catalogue

Spackman Uterine Manipulator/Injector

EUDAMED

Class I (EU MDR)

Ref PS3112NSModel TF1003

by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited

Identity

Trade Name
Spackman Uterine Manipulator/Injector EUDAMED
Device Name
Spackman cannula & Uterine manipulator EUDAMED
Model / Reference
TF1003 EUDAMED
PS3112NS EUDAMED

Identifiers

Primary DI / UDI-DI
05051223023661 EUDAMED
Basic UDI-DI
50512230UTESPACKMANQE EUDAMED
EMDN Code
U080199 GYNAECOLOGICAL CATHETERS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

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

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/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
EUDAMED SRN
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED e5c5fac6-cf77-4a30-a8c0-86d2a7ce7987 61 fields · synced Oct 7, 2026