DRAP registered medical device · imported

SARS CoV-2 Antigen Self Test Nasal [Roche Cat # 09445323077 Reference #

Class C (moderate to high risk) · MDIR-0003190 · Roche Pakistan Ltd.

✓ DRAP status Listed Valid until 23 Jan 2027

Screened against DRAP's published lists

DRAP REGISTERED MEDICAL DEVICE

SARS CoV-2 Antigen Self Test Nasal [Roche Cat # 09445323077 Reference # 9901-NCOV-06G Pack size - 5 Test kit] is registered with DRAP under number MDIR-0003190 as a Class C (moderate to high risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 23 Jan 2027.

Screening result

Imported device, registered with DRAP as Class C (moderate to high risk)
MDIR-0003190 · 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 23 Jan 2027

✓

Holder has a DRAP import licence on file
ELI-00009

Device	SARS CoV-2 Antigen Self Test Nasal [Roche Cat # 09445323077 Reference # 9901-NCOV-06G Pack size - 5 Test kit]
Class	C
Listed holder	Roche Pakistan Ltd.
Holder address	1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400
Manufacturing site	M/s Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany
Issued	24 Jan 2022
Renewal date	23 Jan 2027
Licence	ELI-00009

Specifications

No supplier specifications yet.

Supplier of this device? Add specifications (free during launch)

Screened 7 Oct 2026, 06:07 (Pakistan time). A screening aid, not an official DRAP verification.

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Similar devices from other companies

Same device type listed by other holders, useful when comparing suppliers.

MDMR-000284	R-test SARS-CoV-2 Ag & Flu A/B Combo Rapid Test (Dengue NS1 antigen (DEN1, 2, 3, 4)self…	Class C	Lab Diagnostic Systems (SMC) Pvt. Ltd.
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MDIR-0003682	ALLTEST SARS-COV-2 Antigen Rapid Test ( Nasal Swab) )- Self testing Kits	Class C	RA Healthcare (SMC-Pvt) Ltd
MDIR-0003685	ALLTEST SARS-COV-2 ANTIGEN RAPID TEST (NASAL SWAB)	Class C	RA Healthcare (SMC-Pvt) Ltd
MDIR-0003107	Elecsys SARS-CoV-2 Antigen Test Kit	Class C	Roche Pakistan Ltd

Corrections

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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.