SCULTRA II - DRAP MDIR-0006163 (Class C)

DRAP REGISTERED MEDICAL DEVICE

SCULTRA II (Total Shoulder Prosthesis, STANDARD) is registered with DRAP under number MDIR-0006163 as a Class C (moderate to high risk) medical device, imported. The listed holder is Treu-Dynamic International (Pvt) Ltd. It is listed as valid until 30 Jan 2029.

Screening result

i
Number type: imported, registered (Class B, C or D)
MDIR-0006163
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Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
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Listed valid until 30 Jan 2029
✓
Holder has a DRAP import licence on file
ELI-00175
DeviceSCULTRA II (Total Shoulder Prosthesis, STANDARD)
ClassC
Listed holderTreu-Dynamic International (Pvt) Ltd
Holder addressC-206, 2nd Floor city Towers, Main Boulevard, Gulberg, Lahore.
Manufacturing siteM/s EUROS S.A.S. Z.E. Athelia III 13600 LA Ciotat, France
Issued31 Jan 2024
Renewal date30 Jan 2029
LicenceELI-00175

Specifications

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Screened 5 Oct 2026, 00:49 (Pakistan time). A screening aid, not an official DRAP verification.

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MDIR-0006306Euro Screw NGClass D
MDIR-0006307Gentafix Bone CementClass D
MDIR-0009574Omnipore Reconstruction Surgery Implants.Class C
MDIR-0009575Hydromed Surgical DressingClass D
MDIR-0009612Osteopore PCL Scaffold Bone FillerClass D

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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.