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Disposable Introducer Set
EUDAMEDClass IIa (EU MDR)
Ref OM-IS10-02Ref OM-IS08-02Ref OM-IS05-01Ref OM-IS04-01Ref OM-IS04-02Ref OM-IS07-01Ref OM-IS09-01Ref OM-IS07-03Ref OM-IS09-02Ref OM-IS07-02Ref OM-IS08-03Ref OM-IS10-01Ref OM-IS04-03Ref OM-IS12-01Ref OM-IS11-03Ref OM-IS12-03Ref OM-IS06-02Ref OM-IS06-01
Identity
- Trade Name
- Disposable Introducer Set EUDAMED
- Device Name
- Disposable Introducer Set EUDAMED
- Model / Reference
- OM-IS10-02 EUDAMEDOM-IS08-02 EUDAMEDOM-IS05-01 EUDAMEDOM-IS04-01 EUDAMEDOM-IS04-02 EUDAMEDOM-IS07-01 EUDAMEDOM-IS09-01 EUDAMEDOM-IS07-03 EUDAMEDOM-IS09-02 EUDAMEDOM-IS07-02 EUDAMEDOM-IS08-03 EUDAMEDOM-IS10-01 EUDAMEDOM-IS04-03 EUDAMEDOM-IS12-01 EUDAMEDOM-IS11-03 EUDAMEDOM-IS12-03 EUDAMEDOM-IS06-02 EUDAMEDOM-IS06-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985352037 EUDAMED06972985351993 EUDAMED06972985350873 EUDAMED06972985350859 EUDAMED06972985351955 EUDAMED06972985350958 EUDAMED06972985350989 EUDAMED06972985351986 EUDAMED06972985352013 EUDAMED06972985351979 EUDAMED06972985352006 EUDAMED06972985350996 EUDAMED06972985351962 EUDAMED06972985351016 EUDAMED06972985352068 EUDAMED06972985352082 EUDAMED06972985350927 EUDAMED06972985350910 EUDAMED
- Basic UDI-DI
- B-06972985352037 EUDAMEDB-06972985351993 EUDAMEDB-06972985350873 EUDAMEDB-06972985350859 EUDAMEDB-06972985351955 EUDAMEDB-06972985350958 EUDAMEDB-06972985350989 EUDAMEDB-06972985351986 EUDAMEDB-06972985352013 EUDAMEDB-06972985351979 EUDAMEDB-06972985352006 EUDAMEDB-06972985350996 EUDAMEDB-06972985351962 EUDAMEDB-06972985351016 EUDAMEDB-06972985352068 EUDAMEDB-06972985352082 EUDAMEDB-06972985350927 EUDAMEDB-06972985350910 EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Category: Interventional radiology percutaneous-access kit, single-use
Disposable Introducer Set by Ortus Medi-Tech Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Interventional radiology percutaneous-access kit, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972985352037 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ortus Medi-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000031033
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (18)
- EUDAMED fc1324de-35e8-4f93-b5ef-cd74d1d278ef 61 fields · synced Aug 3, 2026
- EUDAMED 59f25b5f-4a6b-4397-8816-20d94db851e1 61 fields · synced May 16, 2026
- EUDAMED e8e2f9d0-144d-432a-aa92-e7792762fc5f 61 fields · synced May 16, 2026
- EUDAMED 64d8f3c5-bd7c-4c64-a756-f348ef950b9d 61 fields · synced May 16, 2026
- EUDAMED e1678b45-0165-4fa8-b2bb-81bf6a457064 61 fields · synced May 16, 2026
- EUDAMED 407d1638-7f1a-45dd-a967-0c5d2289f845 61 fields · synced May 16, 2026
- EUDAMED 98a83748-6e5f-462b-ad9a-10a56403285b 61 fields · synced May 16, 2026
- EUDAMED a05efdfc-eade-44c4-9537-671501993eef 61 fields · synced May 17, 2026
- EUDAMED 3787e162-058b-470d-97e2-bf59bb13b0d5 61 fields · synced May 17, 2026
- EUDAMED fe4c4346-41bb-4cac-98b4-2529f890bffc 61 fields · synced May 17, 2026
- EUDAMED 478e87e5-8084-4225-801b-550de3af1918 61 fields · synced May 17, 2026
- EUDAMED 355d0bf3-d051-450f-a1f5-9a86a117c2f7 61 fields · synced May 17, 2026
- EUDAMED ff99a4d4-54d1-419a-af40-5b158b0fcbcc 61 fields · synced May 18, 2026
- EUDAMED 5d595068-0980-4ef0-86ad-b0151f3852f6 61 fields · synced May 18, 2026
- EUDAMED 2e3c2596-9c40-46a5-b901-cc27ce483350 61 fields · synced May 18, 2026
- EUDAMED 49caf3db-0b34-43b5-adca-576d31ffc0bf 61 fields · synced May 18, 2026
- EUDAMED 71914ba3-0e2c-4fb8-893d-19eb7b91feaa 61 fields · synced May 19, 2026
- EUDAMED 2262caf2-f9c7-492e-aa04-60b26abd6415 61 fields · synced May 19, 2026