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Medical Device Division · registration 190050Active

ELLA-CS

Hong KongStents, Biliary, Metallic, Self-ExpandingClass IIIELLA-CS, s.r.o.
Verified
Official record identity
MDACS listing number
190050
Model name
SX-ELLA Stent Biliary (Nitinella Plus) (019-01C-08-040, 019-01C-08-040-T, 019-01C-08-060, 019-01C-08-060-T, 019-01C-08-080, 019-01C-08-080-T, 019-01C-08-100, 019-01C-08-100-T, 019-01C-10-030, 019-01C-10-040, 019-01C-10-040-T, 019-01C-10-050, 019-01C-10-060, 019-01C-10-060-T, 019-01C-10-070, 019-01C-10-080, 019-01C-10-080-T, 019-01C-10-100, 019-01C-10-100-T, 019-01D-08-040, 019-01D-08-040-T, 019-01D-08-060, 019-01D-08-060-T, 019-01D-08-080, 019-01D-08-080-T, 019-01D-08-100, 019-01D-08-100-T, 019-01D-10-040, 019-01D-10-040-T, 019-01D-10-060, 019-01D-10-060-T, 019-01D-10-080, 019-01D-10-080-T, 019-01D-10-100, 019-01D-10-100-T), SX-ELLA Stent Biliary (Nitinella Plus) - B (019-01B-08-040, 019-01B-08-040-T, 019-01B-08-060, 019-01B-08-060-T, 019-01B-08-080, 019-01B-08-080-T, 019-01B-08-100, 019-01B-08-100-T, 019-01B-10-030, 019-01B-10-040, 019-01B-10-040-T, 019-01B-10-050, 019-01B-10-060, 019-01B-10-060-T, 019-01B-10-070, 019-01B-10-080, 019-01B-10-080-T, 019-01B-10-100, 019-01B-10-100-T)
Registration date
January 31, 2024
Expiry date
February 25, 2029
Source update date
October 24, 2024
Status
Active
Official value: Valid
Classification
Risk class
Class III
Official value: III
Published category
Stents, Biliary, Metallic, Self-Expanding
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Published parties
Registrant / registration holder
ConMed Limited
Manufacturer
ELLA-CS, s.r.o.
Official description

Stents, Biliary, Metallic, Self-Expanding

Additional source fields
AMD nomenclature code
20421
Traditional Chinese local responsible person
康明醫療有限公司
Local responsible person phone
28544413
Published manufacturer address
Milady Horákové 504/45, Třebeš, 500 06 Hradec Králové, Czech Republic
Revision number
a
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.