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EXTesia Introducer Sheath Set

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 2IS040521PSI510(k) K220604Ref 2IS062538PSIRef 2IS040535PSIRef 2IS052538SSIRef 2IS040725SSNRef 2IS060738SSIRef 2IS060718SSIRef 2IS052535SSIRef 2IS051618SSNRef 2IS050735SSNRef 2IS051621SJIRef 2IS051018SJIRef 2IS072525PSIRef 2IS061018SJIRef 2IS061618SSNRef 2IS071625SSNRef 2IS070735SJIRef 2IS072521PAIRef 2IS061038SSIRef 2IS051638SSNRef 2IS060738SJNRef 2IS050518SJIRef 2IS041000000Ref 2IS061018SJNRef 2IS051018SJNRef 2IS070535SSIRef 2IS050735SJNRef 2IS061635SJNRef 2IS071638SSNRef 2IS070525PSIRef 2IS050538SSNRef 2IS041635SSNRef 2IS070725SJIRef 2IS051038SSIRef 2IS042525PAIRef 2IS070718SJNRef 2IS071018SSIRef 2IS051038PSIRef 2IS051038PAIRef 2IS061638PSIRef 2IS052535SSNRef 2IS042521SSNRef 2IS061625SJNRef 2IS040518SJNRef 2IS070738PSIRef 2IS071638PAIRef 2IS062518SSIRef 2IS050518SJNRef 2IS042535PSIRef 2IS070535PSIRef 2IS050725SJIRef 2IS040718SJIRef 2IS062521SSIRef 2IS061025SJIRef 2IS042521PAIRef 2IS040700000Ref 2IS041625SSNRef 2IS071625SJIRef 2IS042525SJNRef 2IS071621SJNRef 2IS071021SJIRef 2IS052538PAIRef 2IS050525SSNRef 2IS061625SSNRef 2IS060521SSNRef 2IS062521PAIRef 2IS060538PAIRef 2IS050735PAIRef 2IS040535PAIRef 2IS070525SJNRef 2IS041035PAIRef 2IS051600000Ref 2IS050721SJNRef 2IS050738SJNRef 2IS042525SJIRef 2IS071625SJNRef 2IS061638SSIRef 2IS052500000Ref 2IS060538SSNRef 2IS040735SSNRef 2IS070738SSNRef 2IS072538SSNRef 2IS071635PAIRef 2IS042535SSNRef 2IS061018SSIRef 2IS052538SSNRef 2IS061621SSIRef 2IS060725SJNRef 2IS070725SSIRef 2IS060525PAIRef 2IS060525SJIRef 2IS051635PAIRef 2IS071621PSIRef 2IS061038PAIRef 2IS051025SJIRef 2IS062535SJNRef 2IS040535SSNRef 2IS072521SJNRef 2IS051635SJIRef 2IS060738PSIRef 2IS041025SJIRef 2IS050725PSIRef 2IS071025SJIRef 2IS060735SJIRef 2IS050521SJIRef 2IS050525PAIRef 2IS060718SJIRef 2IS050535SSNRef 2IS050735SSIRef 2IS071621SJIRef 2IS070521SJIRef 2IS062535SJIRef 2IS061000000Ref 2IS072538SJNPAIRef 2IS062500000Ref 2IS060725PAIRef 2IS040518SSIRef 2IS050525SSIRef 2IS052521PAIRef 2IS042521SJNRef 2IS041025SSIRef 2IS071621SSNRef 2IS061021SJIRef 2IS060535SJNRef 2IS051038SJIRef 2IS050738PAIRef 2IS040525SSNRef 2IS061621SJNRef 2IS040735PSIRef 2IS051625SJNRef 2IS070521PSIRef 2IS041035SJNRef 2IS071000000Ref 2IS061625PSIRef 2IS050535PAIRef 2IS061621SSNRef 2IS040500000Ref 2IS041625PSIRef 2IS051638SJNRef 2IS070725PAIRef 2IS060535PAIRef 2IS061621PSIRef 2IS070738SSIRef 2IS041621SJIRef 2IS041635SJIRef 2IS060735SSNRef 2IS060725SJIRef 2IS062535PSIRef 2IS041035SSNRef 2IS041021PAIRef 2IS060518SJNRef 2IS052518SJNRef 2IS041025PAIRef 2IS070718SSNRef 2IS062538SJNRef 2IS050718SJNRef 2IS050538SJIRef 2IS050721SJIRef 2IS072521SSNRef 2IS062525SJIRef 2IS071021PSIRef 2IS071035PSIRef 2IS051038SSNRef 2IS062535SSIRef 2IS072521PSIRef 2IS051035SSIRef 2IS070738PAIRef 2IS040518SSNRef 2IS050535PSIRef 2IS060518SSIRef 2IS050718SSNRef 2IS071625PAIRef 2IS070525PAIRef 2IS071635SJIRef 2IS052525PSIRef 2IS071018SJIRef 2IS051021SSIRef 2IS041021SJNRef 2IS070735PSIRef 2IS052535PSIRef 2IS041635PAIRef 2IS061035SSIRef 2IS040525SJNRef 2IS050518SSIRef 2IS070721PAIRef 2IS042525SSIRef 2IS040735PAIRef 2IS040535SJNRef 2IS070518SJIRef 2IS051618SSIRef 2IS042525PSIRef 2IS061035SJNRef 2IS040521SJIRef 2IS071035SJNRef 2IS070518SSNRef 2IS072525PAIRef 2IS062518SJNRef 2IS050538SJNRef 2IS051635SSIRef 2IS061021PSIRef 2IS051625PSIRef 2IS051621PAIRef 2IS071638SJNRef 2IS060738SJIRef 2IS041035PSIRef 2IS061038SSNRef 2IS071018SSNRef 2IS040525PSIRef 2IS070718SSIRef 2IS041635SSIRef 2IS041600000Ref 2IS072538SJIRef 2IS062521SJIRef 2IS052525SJIRef 2IS050500000Ref 2IS060721SSNRef 2IS052525SSIRef 2IS042525SSNRef 2IS070538PAIRef 2IS072535PSIRef 2IS051035PAIRef 2IS061625PAIRef 2IS071635SSIRef 2IS062525PAIRef 2IS071635PSIRef 2IS071038SSIRef 2IS052538PSIRef 2IS070735PAIRef 2IS060721SJIRef 2IS040525PAIRef 2IS052525SSNRef 2IS062525PSIRef 2IS062521PSIRef 2IS071621PAIRef 2IS041635PSIRef 2IS071600000Ref 2IS071025PAIRef 2IS072518SSIRef 2IS041035SJIRef 2IS061035SSNRef 2IS040518SJIRef 2IS041621PSIRef 2IS072538SSIRef 2IS060735PAIRef 2IS061625SSIRef 2IS061635SSNRef 2IS071638SJIRef 2IS041025SSNRef 2IS041618SSIRef 2IS041018SJIRef 2IS072525SJIRef 2IS070735SSNRef 2IS060538SJNRef 2IS040718SSNRef 2IS062538SSIRef 2IS052535SJNRef 2IS050521SSIRef 2IS040525SJIRef 2IS071638PSIRef 2IS061638PAIRef 2IS052521SJNRef 2IS042521PSIRef 2IS042535SSIRef 2IS050735PSIRef 2IS051025SSNRef 2IS041035SSIRef 2IS040735SJNRef 2IS070538SSNRef 2IS051021PSIRef 2IS052525PAIRef 2IS050725SJNRef 2IS040535SSIRef 2IS070738SJIRef 2IS062518SSNRef 2IS061635PAIRef 2IS072500000Ref 2IS070525SJIRef 2IS051025PSIRef 2IS061638SJIRef 2IS051621PSIRef 2IS070721SJIRef 2IS050718SJIRef 2IS052521PSIRef 2IS070725SSNRef 2IS060721SSIRef 2IS062521SJNRef 2IS071625PSIRef 2IS061618SJIRef 2IS052535PAIRef 2IS041618SJIRef 2IS060535SSIRef 2IS062538SSNRef 2IS052518SSNRef 2IS072518SJNRef 2IS072521SSIRef 2IS061635SSIRef 2IS051621SSIRef 2IS041021SSNRef 2IS041621PAIRef 2IS071035SSIRef 2IS060500000Ref 2IS050738SSNRef 2IS052518SJIRef 2IS061621SJIRef 2IS051021SJIRef 2IS060738PAIRef 2IS071618SJIRef 2IS040721SJIRef 2IS050538PAIRef 2IS060718SJNRef 2IS042518SJIRef 2IS040521SSIRef 2IS060718SSNRef 2IS051021SSNRef 2IS051021SJNRef 2IS060521PSIRef 2IS070735SSI

by Curatia Medical Limited

Identity

Trade Name
EXTesia Introducer Sheath Set EUDAMED
EXTesia EUDAMED
Device Name
EXTesia Introducer Sheath Set EUDAMED
Model / Reference
2IS040521PSI EUDAMED
2IS062538PSI EUDAMED
2IS040535PSI EUDAMED
2IS052538SSI EUDAMED
2IS040725SSN EUDAMED
2IS060738SSI EUDAMED
2IS060718SSI EUDAMED
2IS052535SSI EUDAMED
2IS051618SSN EUDAMED
2IS050735SSN EUDAMED
2IS051621SJI EUDAMED
2IS051018SJI EUDAMED
2IS072525PSI EUDAMED
2IS061018SJI EUDAMED
2IS061618SSN EUDAMED
2IS071625SSN EUDAMED
2IS070735SJI EUDAMED
2IS072521PAI EUDAMED
2IS061038SSI EUDAMED
2IS051638SSN EUDAMED
2IS060738SJN EUDAMED
2IS050518SJI EUDAMED
2IS041000000 EUDAMED
2IS061018SJN EUDAMED
2IS051018SJN EUDAMED
2IS070535SSI EUDAMED
2IS050735SJN EUDAMED
2IS061635SJN EUDAMED
2IS071638SSN EUDAMED
2IS070525PSI EUDAMED
2IS050538SSN EUDAMED
2IS041635SSN EUDAMED
2IS070725SJI EUDAMED
2IS051038SSI EUDAMED
2IS042525PAI EUDAMED
2IS070718SJN EUDAMED
2IS071018SSI EUDAMED
2IS051038PSI EUDAMED
2IS051038PAI EUDAMED
2IS061638PSI EUDAMED
2IS052535SSN EUDAMED
2IS042521SSN EUDAMED
2IS061625SJN EUDAMED
2IS040518SJN EUDAMED
2IS070738PSI EUDAMED
2IS071638PAI EUDAMED
2IS062518SSI EUDAMED
2IS050518SJN EUDAMED
2IS042535PSI EUDAMED
2IS070535PSI EUDAMED
2IS050725SJI EUDAMED
2IS040718SJI EUDAMED
2IS062521SSI EUDAMED
2IS061025SJI EUDAMED
2IS042521PAI EUDAMED
2IS040700000 EUDAMED
2IS041625SSN EUDAMED
2IS071625SJI EUDAMED
2IS042525SJN EUDAMED
2IS071621SJN EUDAMED
2IS071021SJI EUDAMED
2IS052538PAI EUDAMED
2IS050525SSN EUDAMED
2IS061625SSN EUDAMED
2IS060521SSN EUDAMED
2IS062521PAI EUDAMED
2IS060538PAI EUDAMED
2IS050735PAI EUDAMED
2IS040535PAI EUDAMED
2IS070525SJN EUDAMED
2IS041035PAI EUDAMED
2IS051600000 EUDAMED
2IS050721SJN EUDAMED
2IS050738SJN EUDAMED
2IS042525SJI EUDAMED
2IS071625SJN EUDAMED
2IS061638SSI EUDAMED
2IS052500000 EUDAMED
2IS060538SSN EUDAMED
2IS040735SSN EUDAMED
2IS070738SSN EUDAMED
2IS072538SSN EUDAMED
2IS071635PAI EUDAMED
2IS042535SSN EUDAMED
2IS061018SSI EUDAMED
2IS052538SSN EUDAMED
2IS061621SSI EUDAMED
2IS060725SJN EUDAMED
2IS070725SSI EUDAMED
2IS060525PAI EUDAMED
2IS060525SJI EUDAMED
2IS051635PAI EUDAMED
2IS071621PSI EUDAMED
2IS061038PAI EUDAMED
2IS051025SJI EUDAMED
2IS062535SJN EUDAMED
2IS040535SSN EUDAMED
2IS072521SJN EUDAMED
2IS051635SJI EUDAMED
2IS060738PSI EUDAMED
2IS041025SJI EUDAMED
2IS050725PSI EUDAMED
2IS071025SJI EUDAMED
2IS060735SJI EUDAMED
2IS050521SJI EUDAMED
2IS050525PAI EUDAMED
2IS060718SJI EUDAMED
2IS050535SSN EUDAMED
2IS050735SSI EUDAMED
2IS071621SJI EUDAMED
2IS070521SJI EUDAMED
2IS062535SJI EUDAMED
2IS061000000 EUDAMED
2IS072538SJNPAI EUDAMED
2IS062500000 EUDAMED
2IS060725PAI EUDAMED
2IS040518SSI EUDAMED
2IS050525SSI EUDAMED
2IS052521PAI EUDAMED
2IS042521SJN EUDAMED
2IS041025SSI EUDAMED
2IS071621SSN EUDAMED
2IS061021SJI EUDAMED
2IS060535SJN EUDAMED
2IS051038SJI EUDAMED
2IS050738PAI EUDAMED
2IS040525SSN EUDAMED
2IS061621SJN EUDAMED
2IS040735PSI EUDAMED
2IS051625SJN EUDAMED
2IS070521PSI EUDAMED
2IS041035SJN EUDAMED
2IS071000000 EUDAMED
2IS061625PSI EUDAMED
2IS050535PAI EUDAMED
2IS061621SSN EUDAMED
2IS040500000 EUDAMED
2IS041625PSI EUDAMED
2IS051638SJN EUDAMED
2IS070725PAI EUDAMED
2IS060535PAI EUDAMED
2IS061621PSI EUDAMED
2IS070738SSI EUDAMED
2IS041621SJI EUDAMED
2IS041635SJI EUDAMED
2IS060735SSN EUDAMED
2IS060725SJI EUDAMED
2IS062535PSI EUDAMED
2IS041035SSN EUDAMED
2IS041021PAI EUDAMED
2IS060518SJN EUDAMED
2IS052518SJN EUDAMED
2IS041025PAI EUDAMED
2IS070718SSN EUDAMED
2IS062538SJN EUDAMED
2IS050718SJN EUDAMED
2IS050538SJI EUDAMED
2IS050721SJI EUDAMED
2IS072521SSN EUDAMED
2IS062525SJI EUDAMED
2IS071021PSI EUDAMED
2IS071035PSI EUDAMED
2IS051038SSN EUDAMED
2IS062535SSI EUDAMED
2IS072521PSI EUDAMED
2IS051035SSI EUDAMED
2IS070738PAI EUDAMED
2IS040518SSN EUDAMED
2IS050535PSI EUDAMED
2IS060518SSI EUDAMED
2IS050718SSN EUDAMED
2IS071625PAI EUDAMED
2IS070525PAI EUDAMED
2IS071635SJI EUDAMED
2IS052525PSI EUDAMED
2IS071018SJI EUDAMED
2IS051021SSI EUDAMED
2IS041021SJN EUDAMED
2IS070735PSI EUDAMED
2IS052535PSI EUDAMED
2IS041635PAI EUDAMED
2IS061035SSI EUDAMED
2IS040525SJN EUDAMED
2IS050518SSI EUDAMED
2IS070721PAI EUDAMED
2IS042525SSI EUDAMED
2IS040735PAI EUDAMED
2IS040535SJN EUDAMED
2IS070518SJI EUDAMED
2IS051618SSI EUDAMED
2IS042525PSI EUDAMED
2IS061035SJN EUDAMED
2IS040521SJI EUDAMED
2IS071035SJN EUDAMED
2IS070518SSN EUDAMED
2IS072525PAI EUDAMED
2IS062518SJN EUDAMED
2IS050538SJN EUDAMED
2IS051635SSI EUDAMED
2IS061021PSI EUDAMED
2IS051625PSI EUDAMED
2IS051621PAI EUDAMED
2IS071638SJN EUDAMED
2IS060738SJI EUDAMED
2IS041035PSI EUDAMED
2IS061038SSN EUDAMED
2IS071018SSN EUDAMED
2IS040525PSI EUDAMED
2IS070718SSI EUDAMED
2IS041635SSI EUDAMED
2IS041600000 EUDAMED
2IS072538SJI EUDAMED
2IS062521SJI EUDAMED
2IS052525SJI EUDAMED
2IS050500000 EUDAMED
2IS060721SSN EUDAMED
2IS052525SSI EUDAMED
2IS042525SSN EUDAMED
2IS070538PAI EUDAMED
2IS072535PSI EUDAMED
2IS051035PAI EUDAMED
2IS061625PAI EUDAMED
2IS071635SSI EUDAMED
2IS062525PAI EUDAMED
2IS071635PSI EUDAMED
2IS071038SSI EUDAMED
2IS052538PSI EUDAMED
2IS070735PAI EUDAMED
2IS060721SJI EUDAMED
2IS040525PAI EUDAMED
2IS052525SSN EUDAMED
2IS062525PSI EUDAMED
2IS062521PSI EUDAMED
2IS071621PAI EUDAMED
2IS041635PSI EUDAMED
2IS071600000 EUDAMED
2IS071025PAI EUDAMED
2IS072518SSI EUDAMED
2IS041035SJI EUDAMED
2IS061035SSN EUDAMED
2IS040518SJI EUDAMED
2IS041621PSI EUDAMED
2IS072538SSI EUDAMED
2IS060735PAI EUDAMED
2IS061625SSI EUDAMED
2IS061635SSN EUDAMED
2IS071638SJI EUDAMED
2IS041025SSN EUDAMED
2IS041618SSI EUDAMED
2IS041018SJI EUDAMED
2IS072525SJI EUDAMED
2IS070735SSN EUDAMED
2IS060538SJN EUDAMED
2IS040718SSN EUDAMED
2IS062538SSI EUDAMED
2IS052535SJN EUDAMED
2IS050521SSI EUDAMED
2IS040525SJI EUDAMED
2IS071638PSI EUDAMED
2IS061638PAI EUDAMED
2IS052521SJN EUDAMED
2IS042521PSI EUDAMED
2IS042535SSI EUDAMED
2IS050735PSI EUDAMED
2IS051025SSN EUDAMED
2IS041035SSI EUDAMED
2IS040735SJN EUDAMED
2IS070538SSN EUDAMED
2IS051021PSI EUDAMED
2IS052525PAI EUDAMED
2IS050725SJN EUDAMED
2IS040535SSI EUDAMED
2IS070738SJI EUDAMED
2IS062518SSN EUDAMED
2IS061635PAI EUDAMED
2IS072500000 EUDAMED
2IS070525SJI EUDAMED
2IS051025PSI EUDAMED
2IS061638SJI EUDAMED
2IS051621PSI EUDAMED
2IS070721SJI EUDAMED
2IS050718SJI EUDAMED
2IS052521PSI EUDAMED
2IS070725SSN EUDAMED
2IS060721SSI EUDAMED
2IS062521SJN EUDAMED
2IS071625PSI EUDAMED
2IS061618SJI EUDAMED
2IS052535PAI EUDAMED
2IS041618SJI EUDAMED
2IS060535SSI EUDAMED
2IS062538SSN EUDAMED
2IS052518SSN EUDAMED
2IS072518SJN EUDAMED
2IS072521SSI EUDAMED
2IS061635SSI EUDAMED
2IS051621SSI EUDAMED
2IS041021SSN EUDAMED
2IS041621PAI EUDAMED
2IS071035SSI EUDAMED
2IS060500000 EUDAMED
2IS050738SSN EUDAMED
2IS052518SJI EUDAMED
2IS061621SJI EUDAMED
2IS051021SJI EUDAMED
2IS060738PAI EUDAMED
2IS071618SJI EUDAMED
2IS040721SJI EUDAMED
2IS050538PAI EUDAMED
2IS060718SJN EUDAMED
2IS042518SJI EUDAMED
2IS040521SSI EUDAMED
2IS060718SSN EUDAMED
2IS051021SSN EUDAMED
2IS051021SJN EUDAMED
2IS060521PSI EUDAMED
2IS070735SSI EUDAMED

Identifiers

Primary DI / UDI-DI
06941358008529 EUDAMED
06941358010874 EUDAMED
06941358008543 EUDAMED
06941358012779 EUDAMED
06941358008741 EUDAMED
06941358012977 EUDAMED
06941358012939 EUDAMED
06941358012762 EUDAMED
06941358009847 EUDAMED
06941358009519 EUDAMED
06941358012694 EUDAMED
06941358012588 EUDAMED
06941358011758 EUDAMED
06941358013080 EUDAMED
06941358010744 EUDAMED
06941358011666 EUDAMED
06941358013516 EUDAMED
06941358011789 EUDAMED
06941358013073 EUDAMED
06941358009885 EUDAMED
06941358010478 EUDAMED
06941358012380 EUDAMED
06941358013851 EUDAMED
06941358010614 EUDAMED
06941358009717 EUDAMED
06941358013363 EUDAMED
06941358009564 EUDAMED
06941358010829 EUDAMED
06941358011680 EUDAMED
06941358011031 EUDAMED
06941358009342 EUDAMED
06941358009038 EUDAMED
06941358013509 EUDAMED
06941358012571 EUDAMED
06941358009120 EUDAMED
06941358011338 EUDAMED
06941358013530 EUDAMED
06941358009618 EUDAMED
06941358009656 EUDAMED
06941358010690 EUDAMED
06941358010058 EUDAMED
06941358009151 EUDAMED
06941358010812 EUDAMED
06941358008628 EUDAMED
06941358011239 EUDAMED
06941358011635 EUDAMED
06941358013233 EUDAMED
06941358009359 EUDAMED
06941358009106 EUDAMED
06941358011048 EUDAMED
06941358012502 EUDAMED
06941358012052 EUDAMED
06941358013240 EUDAMED
06941358013103 EUDAMED
06941358009113 EUDAMED
06941358013844 EUDAMED
06941358009021 EUDAMED
06941358013707 EUDAMED
06941358009205 EUDAMED
06941358011703 EUDAMED
06941358013592 EUDAMED
06941358010010 EUDAMED
06941358009328 EUDAMED
06941358010768 EUDAMED
06941358010218 EUDAMED
06941358010881 EUDAMED
06941358010195 EUDAMED
06941358009465 EUDAMED
06941358008574 EUDAMED
06941358011178 EUDAMED
06941358008857 EUDAMED
06941358013912 EUDAMED
06941358009540 EUDAMED
06941358009571 EUDAMED
06941358012311 EUDAMED
06941358011710 EUDAMED
06941358013172 EUDAMED
06941358013929 EUDAMED
06941358010249 EUDAMED
06941358008758 EUDAMED
06941358011321 EUDAMED
06941358011864 EUDAMED
06941358011628 EUDAMED
06941358009175 EUDAMED
06941358013035 EUDAMED
06941358010065 EUDAMED
06941358013141 EUDAMED
06941358010454 EUDAMED
06941358013455 EUDAMED
06941358010171 EUDAMED
06941358012908 EUDAMED
06941358009823 EUDAMED
06941358011567 EUDAMED
06941358010553 EUDAMED
06941358012601 EUDAMED
06941358011000 EUDAMED
06941358008611 EUDAMED
06941358011888 EUDAMED
06941358012717 EUDAMED
06941358010331 EUDAMED
06941358012151 EUDAMED
06941358009410 EUDAMED
06941358013608 EUDAMED
06941358013011 EUDAMED
06941358012397 EUDAMED
06941358009274 EUDAMED
06941358012984 EUDAMED
06941358009335 EUDAMED
06941358012465 EUDAMED
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Basic UDI-DI
697022652107FS EUDAMED
EMDN Code
C0504 ARTERIAL INTRODUCTION SETS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Estonia EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Interventional radiology percutaneous-access kit, single-use

EXTesia Introducer Sheath Set by Curatia Medical Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Interventional radiology percutaneous-access kit, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Curatia Medical Limited
EUDAMED SRN
CN-MF-000015976
FDA Applicant
Curatia Medical Co.
Authorised Representative
MedNet EC-REP III GmbH DE-AR-000011191

Sources (318)

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  • EUDAMED 32d12499-0560-408c-ad31-b5bba3c1293a 61 fields · synced Sep 18, 2026
  • EUDAMED 4705932b-b54a-4d19-b7c0-5242fcf278c9 61 fields · synced Sep 18, 2026
  • EUDAMED 2c755d01-84fa-43fa-b6bb-6ba23159fb51 61 fields · synced Sep 18, 2026
  • EUDAMED 9deca940-c261-4b0a-bba8-ff54ba974b2b 61 fields · synced Sep 18, 2026
  • EUDAMED 77d1b8b0-e0c4-4591-b505-ecfb5a16c0d6 61 fields · synced Sep 30, 2026
  • EUDAMED 686eb12d-4a15-4603-9ceb-59fd6c538c20 61 fields · synced Oct 1, 2026
  • FDA 510(k) K220604 1 fields · synced May 18, 2026