ISO 13485 · CE MDR · FDA-Registered Facility

Apto engineers surgical, dental and aesthetic instruments for hospitals and distributors in 40+ countries — machined to ±0.005 mm, validated to ISO 11607, and delivered on time.

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  • ISO 13485certified QMS
  • 40+export countries
  • ±0.005mm tolerance
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◆ ISO 13485 CERTIFIED ◆ CE MDR 2017/745 ◆ FDA REGISTERED ◆ ISO 11607 STERILE BARRIER ◆ 100% DIMENSIONAL INSPECTION ◆ HEAT-LOT TRACEABILITY ◆ ISO 13485 CERTIFIED ◆ CE MDR 2017/745 ◆ FDA REGISTERED ◆ ISO 11607 STERILE BARRIER ◆ 100% DIMENSIONAL INSPECTION ◆ HEAT-LOT TRACEABILITY

Twelve years of exactness

Every Apto instrument is a promise measured in microns.

We are an Indian instrument house that builds to international medical-device standards. One metallurgy lab, one metrology room, one traceability pipeline — applied across four divisions and more than 1,200 active references.

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On-time dispatch
A surgeon's hands working with precision instruments in a sterile field

Sterile field · Class I devices

“The instrument in your hand should disappear. Only the procedure should remain.”

Product divisions

Four divisions.
One standard of craft.

Surgical instruments arranged on a tray
01

Surgical

Forceps, needle holders, retractors and dissection sets in mill-certified 420/440C stainless.

  • General surgery
  • Cardiovascular
  • Orthopaedics
Explore surgical
Dental instruments laid out in a clinic
02

Dental

Explorers, mirrors, extraction sets and examination kits — fully autoclavable and corrosion-tested.

  • Restorative
  • Orthodontics
  • Oral surgery
Explore dental
A fine aesthetic procedure being performed on a face
03

Aesthetic

Fine-gauge instruments for cosmetic, plastics and dermatology practice with a mirror-perfect finish.

  • Plastic surgery
  • Dermatology
  • Injectables
Explore aesthetic
A clinician practising on a medical training manikin
04

Training

Institutional models and simulated-tissue sets for residency programmes and skills labs.

  • Simulation
  • Suturing sets
  • Task trainers
Explore training

Featured catalogue

Instruments built
for daily fidelity.

Eight flagship references. Open any product for a studio view, finish options and an instant quotation path.

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Manufacturing capability

From alloy to instrument.
A controlled process.

Scroll through the pipeline. The visual advances with you, stage by stage, from CAD model to released lot.

Close-up of a CNC machine in operation Molten steel being poured at a steel mill CNC milling machine cutting metal with coolant Machined metal tool surface detail Laboratory testing with a microscope

Stage 01

± 0.005 mm machining tolerance

  1. 01

    DFM & CAD engineering

    In-house design for manufacturability with full 3D metrology checks before a single bar is cut.

  2. 02

    Alloy sourcing

    Mill-certified 316L, 420/440C stainless and titanium — traceable to heat number.

  3. 03

    Precision machining

    5-axis CNC turning, milling and grinding holding tolerances to ±0.005 mm.

  4. 04

    Finishing & passivation

    Electro-polish, satin mirror and matte finishes — passivated for corrosion resistance.

  5. 05

    QC & validation

    100% dimensional inspection, NDT sampling, and packaging validated to ISO 11607.

Quality & compliance

Certified, audited,
traceable end to end.

Our quality system is externally audited to international medical-device standards. Every batch ships with its paperwork.

A scientist examining samples under a microscope
Metrology & inspection room · Mumbai

  • ISO 13485

    Medical device quality management system — externally audited, current certificate.

  • CE MDR

    Class I devices under MDR (EU) 2017/745 with technical documentation on file.

  • FDA Registered

    Registered establishment for surgical and dental instrument manufacturing.

  • ISO 11607

    Packaging validated for sterility maintenance via sterile-barrier systems.

Every lot, verifiable

  • Heat-lot traceability on all raw alloy
  • 100% dimensional inspection, first-article reports
  • Batch release with COC and packing list
  • OEM branding, laser engraving, drop-ship available
A factory production line

Common questions

MOQ is 100 units per reference for stock ranges, and 500 units for custom OEM design. Evaluation samples are available from stock.

Yes. OEM labelling, laser engraving, logo-applied packaging and quality-holder certification are offered across all divisions.

Material certificates, inspection reports and conformity documentation ship with every order, downloadable from your account portal.

Stock references dispatch in 7–12 working days; OEM runs in 4–6 weeks. We quote FOB, CIF and DDP worldwide.

Request a quotation

Tell us what you need.
We’ll respond in 24h.

Three short steps. A sales engineer — not a bot — will review your requirements and return a firm, itemised quotation with lead times.

  • 24h response on stock references
  • Free evaluation samples for qualified buyers
  • FOB / CIF / DDP incoterms worldwide

Direct line

sales@aptoinstruments.com

Product & volume

Specification
Surface finish
Sterilisation & packaging
Contact

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