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iCLAS™ Shaped Stylet Accesory

EUDAMED

Class I (EU MDR)

Ref 109-0014-004Model MEDIUM CIRCLE 30-8-20Ref 109-0014-011Model MEDIUM FLUTTERRef 109-0014-022Model C-SHAPED FLUTTERRef 109-0014-023Model FULL COIL FLUTTERRef 109-0014-008Model MEDIUM CIRCLE 150, 30-8-15Ref 109-0014-007Model SMALL CIRCLE 90, 25-8-15Ref 109-0014-018Model MEDIUM CIRCLE 30-40-20, J-TIPRef 109-0014-012Model SMALL FLUTTERRef 109-0014-019Model LARGE CIRCLE 35-15-20Ref 109-0014-020Model FOCAL STRAIGHT 10-20-10Ref 109-0014-002Model SMALL CIRCLE 25-8-10Ref 109-0014-005Model LARGE CIRCLE 35-15-15Ref 109-0014-015Model SMALL CIRCLE 25-15-15Ref 109-0014-016Model MEDIUM CIRCLE 30-15-20

by Adagio Medical, Inc.

Identity

Trade Name
iCLAS™ Shaped Stylet Accesory EUDAMED
Device Name
iCLAS™ Shaped Stylet Accessory EUDAMED
Model / Reference
MEDIUM CIRCLE 30-8-20 EUDAMED
109-0014-004 EUDAMED
MEDIUM FLUTTER EUDAMED
109-0014-011 EUDAMED
C-SHAPED FLUTTER EUDAMED
109-0014-022 EUDAMED
FULL COIL FLUTTER EUDAMED
109-0014-023 EUDAMED
MEDIUM CIRCLE 150, 30-8-15 EUDAMED
109-0014-008 EUDAMED
SMALL CIRCLE 90, 25-8-15 EUDAMED
109-0014-007 EUDAMED
MEDIUM CIRCLE 30-40-20, J-TIP EUDAMED
109-0014-018 EUDAMED
SMALL FLUTTER EUDAMED
109-0014-012 EUDAMED
LARGE CIRCLE 35-15-20 EUDAMED
109-0014-019 EUDAMED
FOCAL STRAIGHT 10-20-10 EUDAMED
109-0014-020 EUDAMED
SMALL CIRCLE 25-8-10 EUDAMED
109-0014-002 EUDAMED
LARGE CIRCLE 35-15-15 EUDAMED
109-0014-005 EUDAMED
SMALL CIRCLE 25-15-15 EUDAMED
109-0014-015 EUDAMED
MEDIUM CIRCLE 30-15-20 EUDAMED
109-0014-016 EUDAMED

Identifiers

Primary DI / UDI-DI
D-109-0014-004SS EUDAMED
D-109-0014-011SP EUDAMED
D-109-0014-022SU EUDAMED
D-109-0014-023SW EUDAMED
D-109-0014-008T2 EUDAMED
D-109-0014-007SY EUDAMED
D-109-0014-018T5 EUDAMED
D-109-0014-012SR EUDAMED
D-109-0014-019T7 EUDAMED
D-109-0014-020SQ EUDAMED
D-109-0014-002SN EUDAMED
D-109-0014-005SU EUDAMED
D-109-0014-015SX EUDAMED
D-109-0014-016SZ EUDAMED
Basic UDI-DI
B-109-0014-004SS EUDAMED
B-109-0014-011SP EUDAMED
B-109-0014-022SU EUDAMED
B-109-0014-023SW EUDAMED
B-109-0014-008T2 EUDAMED
B-109-0014-007SY EUDAMED
B-109-0014-018T5 EUDAMED
B-109-0014-012SR EUDAMED
B-109-0014-019T7 EUDAMED
B-109-0014-020SQ EUDAMED
B-109-0014-002SN EUDAMED
B-109-0014-005SU EUDAMED
B-109-0014-015SX EUDAMED
B-109-0014-016SZ EUDAMED
EMDN Code
C020380 ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

iCLAS™ Shaped Stylet Accesory by Adagio Medical, Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Adagio Medical, Inc.
EUDAMED SRN
US-MF-000001129
Authorised Representative
Qualrep Services B.V. NL-AR-000000537

Sources (14)

  • EUDAMED 5ce374fc-4f9e-4e10-938f-7f524602f676 61 fields · synced Sep 30, 2026
  • EUDAMED b4a02459-e796-4aea-940f-271fd4d1cf32 61 fields · synced May 16, 2026
  • EUDAMED 6c44ce21-8d29-42b6-9fdb-016a4c8ed0b4 61 fields · synced May 16, 2026
  • EUDAMED 903c87f0-f0b3-4ae9-80d5-d8f114243424 61 fields · synced May 17, 2026
  • EUDAMED f434b85e-fcfe-433c-8155-70ba9755b324 61 fields · synced May 17, 2026
  • EUDAMED 4ae016a8-e196-4ec1-b2d4-a20ca6de4e29 61 fields · synced May 17, 2026
  • EUDAMED d85af79b-6fdb-4368-808b-47e3f8fc34af 61 fields · synced May 17, 2026
  • EUDAMED 35dfee59-8a8c-4bef-98a7-6c30d942ad6f 61 fields · synced May 18, 2026
  • EUDAMED 8e9c3584-ff53-4f1a-9a0e-8a9aeaf14edd 61 fields · synced May 18, 2026
  • EUDAMED 900eb348-ff9d-4b30-9112-de458f0d852f 61 fields · synced May 18, 2026
  • EUDAMED 9a373048-7a00-47ef-ab72-45de1cac589d 61 fields · synced May 18, 2026
  • EUDAMED 4ea613f7-7f9d-41c7-9070-92b7b3080518 61 fields · synced May 18, 2026
  • EUDAMED e0bd8879-6ab4-4641-bb87-060c797e11eb 61 fields · synced May 18, 2026
  • EUDAMED 95514ac5-6f15-4f31-85a4-a369f7606283 61 fields · synced May 19, 2026