Products: Medical Division; Clean Room Facilities
Contract Manufacture/Packing
We can supply a full range of manufacture and packing services, in an approved clean room environment, including single-packed or double-packed, from small pouch packing to high volume 4 sided seal or thermoform fill-seal packing, including design and print of labelling.
The facility is 5 years old, 135 square metres, currently operating and monitored to ISO class 7.
With the clean room complex there are 3 rooms; a product wash room, a storage/equipment room and an assembly/packaging room. This area was designed and built for the manufacture and packaging of class 2 and 3 medical devices.
Products: Medical Division; Medical Devices
Our medical division offers a diverse range of products and services which combine modern medical manufacturing techniques with over 270 years of experience in needle-making. We are please to offer:
- Clean room facilities
- Allergy lancets
- Eyed surgical needles
- Suture needles
- Blood lancets/wires
- Flat lancets
- Foetal scalp electrodes
Medical products can be supplied either in bulk quantities or fully packaged. When packaged, our own brand names are available as standard though we are always happy to package under the customer's own brand where it is preferable.
The medical division is registered to ISO 9001: 2000 and BS EN ISO 13485: 2000 and all of our own-brand packaged products are CE marked.
We have placed on the market, class 2a, 2b and 3 medical devices, under the European Medical Device Directive 93/42/EEC.
Entaco is FDA registered under registration 8043734 and is currently manufacturing and packing medical devices for American customers under FDA QSR 21 CFR 820.
We are always happy to provide you with information, catalogues, quotations or advice. Contact us.
There is also an adjoining area of 260 square metres, for larger medical devices and bigger batches. Particle counts meet the ISO class 8 requirement.
This area currently manufactures medical devices and shows a consistently low bioburden. The room has injection moulding machines, presses, assembly machines, sealing and thermoform sealing machines.
For more information on our clean room facilities please contact us.