Elecsys CEA [CAT #: 09755616190 Pack size: 100 Tests CAT - DRAP MDIR-0009873 (Class C)

DRAP REGISTERED MEDICAL DEVICE

Elecsys CEA [CAT #: 09755616190 Pack size: 100 Tests CAT #: 04491777190 Pack size: 200 Tests CAT #: 07027079214 Pack size: 300 Tests is registered with DRAP under number MDIR-0009873 as a Class C (moderate to high risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 29 Jul 2030.

Screening result

i
Imported device, registered with DRAP as Class C (moderate to high risk)
MDIR-0009873 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 29 Jul 2030
✓
Holder has a DRAP import licence on file
ELI-00009
DeviceElecsys CEA [CAT #: 09755616190 Pack size: 100 Tests CAT #: 04491777190 Pack size: 200 Tests CAT #: 07027079214 Pack size: 300 Tests
ClassC
Listed holderRoche Pakistan Ltd.
Holder address1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400, Godown: R-Pl, Plot No. 56, Sector 15, K.I.A, Karachi
Manufacturing siteM/s Roche Diagnostics GmbH Sandhofer Str.116, 68305 Mannheim, Germany Roche Diagnostics (Suzhou) Ltd. No.259 Zhongyuan Road 215028 Suzhou, Jiangsu China Roche Diagnostics GmbH Sandhofer Str.116, 68305 Mannheim, Germany
Issued30 Jul 2025
Renewal date29 Jul 2030
LicenceELI-00009

Specifications

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Screened 5 Oct 2026, 18:37 (Pakistan time). A screening aid, not an official DRAP verification.

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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.