TR
ENBIOMEDICAL® OEM
Manufacturing
High-Volume Contract Manufacturing · Two Divisions · Fully Automated Lines · Global Delivery
Full technical catalogue — construction, materials, performance and packaging.
From Raw Material to Delivery
Biomedical is not simply a product supplier — it is a high-volume strategic manufacturing partner, running fully automated lines with no manual sewing or packaging step.
Manufacturing capability is organised into two divisions that share one engineering core and one certified quality management system, so a single qualification covers the whole production scope.
Manufacturing Capabilities
Precision Molding
Cleanroom injection molding for high-pressure fluid management components and vascular disposables.
Adhesive Coating & Laminating
Medical-grade adhesive systems coated and laminated on breathable membranes and technical textiles.
Ultrasonic Welding
Fabric-to-sole joining at molecular level with millimetre precision — no thread, no needle, no perforation.
Converting & Die-Cutting
Rolls, sheets, perforated, windowed and custom die-cut formats to specification.
Cleanroom Production
Controlled-environment manufacturing with in-line process control and particle management.
Automated Packaging
Fully automated pouch and carton lines with GS1 DataMatrix traceability on every unit.
Production Power
The production model is built for volume, consistency and scale — three stages from incoming material to shipped carton.
Raw Material
Medical-grade polymers, technical textiles and adhesive systems, incoming-inspected and batch-released.
Automated Production
Automated lines that eliminate the risks of manual sewing and packaging, with in-process control at each stage.
Global Delivery
Uninterrupted logistics infrastructure serving the European, Asian and American markets.
capacity (units)
no manual touch
private label
Americas
Material & Construction
Soft Armor boot and shoe covers are built as a layered construction, with the same sole platform across every grade and format.
| Dimension | Boot-covers | Shoe-covers |
|---|---|---|
| Body length | 40 cm | 16 cm |
| Elastic depth | 7 cm | 7 cm |
| Sole sizing | EU size 47 | EU size 47 |
Within the same grade, the two formats differ only in body length. Upper material, grammage, quality and sole are identical.
Production Scope
| Division | Reference | Product | Grade |
|---|---|---|---|
| Specialty Tapes & Safety Clothing | BM-GB01 | Medical Boot-cover — 40 cm | Medical Device — CE Class I |
| BM-GB04 | Medical Shoe-covers — 16 cm | Medical Device — CE Class I | |
| BM-PP01 | PPE Boot — 40 cm | PPE — Reg. (EU) 2016/425 | |
| BM-PP04 | PPE Shoe-cover — 16 cm | PPE — Reg. (EU) 2016/425 | |
| Specialty Tapes & Safety Clothing | Surgical Incision Drape — on rolls (15, 30, 45, 60, 102 cm) or pre-cut, custom cuts and windows | ||
| Protective apparel — high-visibility emergency clothing, protective suits, technical T-shirts | |||
| Cardiovascular & Angiographic Disposables | Angiographic manifolds and kit sets, three-way stopcocks, syringes, Y-connectors, infusion set accessories and components | ||
| Disposable VascuStop bulldog clamps — maxi, mini and micro configurations | |||
OEM / OBL Production Model
We manufacture under your brand or ours. The programme runs from concept and tooling through to validated serial production and shipment.
Specification
Product definition, material selection and performance target agreed with the customer.
Tooling & Validation
In-house tool design, sampling and validation before serial release.
Serial Production
Automated, validated serial output with batch documentation and full traceability.
Programme options: production under your own brand identity, neutral unbranded supply, or a full own-brand label (OBL) programme covering specification, artwork, packaging and documentation.
Quality & Compliance
ISO 13485:2016— Quality Management SystemCertificate scope expressly covers the manufacture and sale of surgical incision drapes, surgical drapes and gowns, overshoes and high-visibility warning clothing — together with OEM/OBL manufacture on behalf of other manufacturers.MDR (EU) 2017/745— CE Medical DeviceMedical grade range — Class I, MD symbol applied(EU) 2016/425— PPEPPE grade range — Personal Protective Equipment- Batch TraceabilityBatch documentation and GS1 DataMatrix identification on every carton
Testing basis: technical testing and analysis carried out by accredited independent European laboratories. The EU and EC Declarations of Conformity are issued by the manufacturer under our ISO 13485:2016 certified quality management system. Certificates and test reports are available on request for evaluation, tendering or registration files.
Packaging & Logistics
| Reference | Format | Units per carton | Net weight |
|---|---|---|---|
| BM-GB01 | Medical Boot-cover | 500 pcs (2 × 250) in nylon pouches | 9.2 kg |
| BM-GB04 | Medical Shoe-covers | 1,000 pcs (4 × 250) in nylon pouches | 10.8 kg |
| BM-PP01 | PPE Boot | 500 pcs (2 × 250) in nylon pouches | 9.2 kg |
| BM-PP04 | PPE Shoe-cover | 1,000 pcs (4 × 250) in nylon pouches | 10.8 kg |
| Carton dimensions | 40 × 40 × 60 cm |
| Identification | GS1 DataMatrix and barcode on every carton |
| Shelf life | 5 years — aseptic integrity guaranteed |
| Storage | Cool, dry place away from direct sunlight · 5°C–45°C · away from moisture and humidity |
Discuss a Manufacturing Programme
Send us your product group, target market and expected volume — we will return the technical dossier, production lead times and a quotation.