Compliance & documentation
Every claim on this site has a certificate behind it.
Licences, standards and per-lot release documents — organised the way a procurement audit asks for them. Documents are issued per enquiry to your email or WhatsApp; nothing is anonymously downloadable.
The audit trail, per lot
D1
CoC
conformity per consignment
D2
CoA
analysis per lot
D3
FSC
free sale certificate
D4
ISO cert
factory QMS scope
D5
DRAP file
licence + registration
Company licences & registrations
Instrument
Number
Scope
Status
Copy
DRAP Establishment Licence
ELI 00850
Import + distribution of Class A medical devices
● Active
Device Registrations
per-product
SteriCraft®, PolarCraft™, EchoGrand™ lines
● Active
Drug Sale Licence
052/DSL(D)/PS&DC-ICT/2026
Lawful sale and distribution, Islamabad
● Active
National Tax Number
4053194-5
FBR income tax registration · active filer
● Active
Sales Tax Registration
2600405319414
FBR registered · active filer
● Active
ISO 13485 : 2016
per-factory
QMS of 3 partner factories — 3 certificates in total, manufacturing scope
● Active
DOC Certificates
per-product
Declaration of Conformity — CE marking under EU MDR 2017/745
● Active
Standards map — which standard covers what
EN 868-2 / -5
Packaging materials
Requirements and test methods for sterilization wrap (−2) and heat-sealable pouches and reels (−5).
Crepe paper · flat reels · Tyvek reels
ISO 11607-1
Terminally sterilized packaging
Materials, sterile barrier systems and packaging system validation requirements.
All SteriCraft® barrier lines
ISO 11140-1
Chemical indicators
Classification and performance of Class 1–6 indicators for sterilization processes.
Strips · tapes · reel print
ISO 11140-4 / EN 285
Bowie-Dick testing
Class 2 indicators for daily air-removal testing of pre-vacuum steam sterilizers.
SC-BD test packs
ANSI/AAMI EC12
ECG electrodes
Performance requirements for disposable ECG electrodes: impedance, offset, defibrillation recovery.
PolarCraft™ PCDEE series
EU MDR 2017/745
CE marking
European regulation governing device classification, conformity assessment and vigilance.
All CE-marked productsRequest a documentation pack
Tender pack
✓CoC + CoA specimen
✓FSC + ISO certificates
✓DRAP licence copies
✓Specification texts per BOQ line
Product dossier
✓Technical data sheet
✓Standards conformity matrix
✓Validation summaries
✓IFU + labelling specimen
Audit pack
✓QMS scope statement
✓Traceability procedure
✓Mock recall record
✓Depot storage certificates