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Medical Device Division · registration 241121Active

Penumbra

Hong KongCatheters, Vascular, Embolectomy/ThrombectomyClass IVPenumbra, Inc.
Official record identity
MDACS listing number
241121
Model name
Aspiration Catheter (CAT6, CAT6KIT, CAT8TORQ85, CAT8XTORQ115, CAT8TORQ85KIT, CAT8XTORQ115KIT, CATD, CAT7DKIT, LITNG7XTORQ130, LITNG12XTORQ115, LITNG12HTORQ115, LITNGFHT100BER, LITNGFHT100H1, LITNGFHT115BER, LITNGFHT115H1, LITNGFHT80BER, LITNGFHT80H1, LITNGFXT100BER, LITNGFXT100H1, LITNGFXT80BER, LITNGFXT80H1, LITNGBT7STR130, LITNGBT7TQ130, LITNGBT7XTQ130, LITNGFB12XT100, LITNGFB12HT100, LITNGFB12XT115, LITNGFB12HT115, LITNGBT6XTX, LITNGBT6XTX150), Separator (SEPD, SEP6, SEP8, SEP7, SEP12, SEP7D, SEP5), Aspiration Tubing (IST3, IST4)
Registration date
April 22, 2026
Expiry date
October 15, 2029
Source update date
April 23, 2026
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Catheters, Vascular, Embolectomy/Thrombectomy
Published parties
Registrant / registration holder
Asia Actual Limited
Manufacturer
Penumbra, Inc.
Official description

Catheters, Vascular, Embolectomy/Thrombectomy

Additional source fields
AMD nomenclature code
10714
Local responsible person phone
28933118
Published manufacturer address
One Penumbra Place, Alameda, CA 94502, USA
Revision number
c
About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.