Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
GB-MF-000012819 · United Kingdom · Shenley
Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited is registered in the European database on medical devices as a manufacturer, with 503 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 371 |
|---|---|
| Class IIb | 132 |
Most frequent device types declared: TF-1020, TF-1024, TF-1031, TF-1033, TF-1036.
Among these devices, 293 are declared sterile, 7 implantable, 1 reusable.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- 5mm/33cm Monopolar Electrode L Hook with 8mm cable
- Bipolar Maryland Dissecting Forceps, without Ratchet, 5mm x 33cm
- Bipolar Straight Grasping Forceps, without Ratchet, 5mm x 33cm
- Curette, Rigid, Straight, 10mm
- Dilating Tip Trocar, Ribbed, 10x100mm
- Dilating Tip Trocar, Ribbed, plus Extra Cannula, 10×100 mm
- Monopolar Metzenbaum Scissors, without Ratchet, 5mm x 33cm
- Ribbed Cannula, 12 × 100 mm
- Silicone Vessel Loops, Mini, Blue - Pair
- Spackman Uterine Manipulator/Injector
- Specimen Cup - Clear
- Suction Connecting Tubing 3.65 m × 7 mm Female/Female/Male
Showing 12 of 503 declared devices.
Catalogue references include PS3003, PS3566ULTNS, PS3881C8, PS4582, PS4583, PS6000A.
European nomenclature codes declared: K01010101, Z12010780, A060102, K0201010602, H020201010102, K0201010301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 503 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 501 |
|---|---|
| Found in the U.S. device database | 100 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited was not found in either the U.S. or the Canadian register.