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Disposable Guide Wire
EUDAMEDClass IIa (EU MDR)
Ref OM-GW-P38150SRef OM-GW-P21150SRef OM-GW-P25180JRef OM-GW-P32150JRef OM-GW-P25260JRef OM-GW-P32260JRef OM-GW-P25150SRef OM-GW-P14150JRef OM-GW-P38180JRef OM-GW-P21260SRef OM-GW-P28260JRef OM-GW-P14180SRef OM-GW-P35180JRef OM-GW-P38180SRef OM-GW-P18150SRef OM-GW-P18150JRef OM-GW-P32180SRef OM-GW-P35150SRef OM-GW-P25150JRef OM-GW-P25260SRef OM-GW-P18180JRef OM-GW-P35150JRef OM-GW-P18260SRef OM-GW-P21180SRef OM-GW-P14260J
Identity
- Trade Name
- Disposable Guide Wire EUDAMED
- Device Name
- Disposable Guide Wire EUDAMED
- Model / Reference
- OM-GW-P38150S EUDAMEDOM-GW-P21150S EUDAMEDOM-GW-P25180J EUDAMEDOM-GW-P32150J EUDAMEDOM-GW-P25260J EUDAMEDOM-GW-P32260J EUDAMEDOM-GW-P25150S EUDAMEDOM-GW-P14150J EUDAMEDOM-GW-P38180J EUDAMEDOM-GW-P21260S EUDAMEDOM-GW-P28260J EUDAMEDOM-GW-P14180S EUDAMEDOM-GW-P35180J EUDAMEDOM-GW-P38180S EUDAMEDOM-GW-P18150S EUDAMEDOM-GW-P18150J EUDAMEDOM-GW-P32180S EUDAMEDOM-GW-P35150S EUDAMEDOM-GW-P25150J EUDAMEDOM-GW-P25260S EUDAMEDOM-GW-P18180J EUDAMEDOM-GW-P35150J EUDAMEDOM-GW-P18260S EUDAMEDOM-GW-P21180S EUDAMEDOM-GW-P14260J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985351283 EUDAMED06972985351221 EUDAMED06972985352150 EUDAMED06972985351153 EUDAMED06972985352167 EUDAMED06972985352204 EUDAMED06972985351238 EUDAMED06972985351108 EUDAMED06972985352228 EUDAMED06972985352280 EUDAMED06972985352181 EUDAMED06972985352235 EUDAMED06972985352211 EUDAMED06972985352365 EUDAMED06972985351214 EUDAMED06972985351115 EUDAMED06972985352334 EUDAMED06972985351269 EUDAMED06972985351139 EUDAMED06972985352303 EUDAMED06972985352112 EUDAMED06972985351160 EUDAMED06972985352266 EUDAMED06972985352273 EUDAMED06972985352105 EUDAMED
- Basic UDI-DI
- B-06972985351283 EUDAMEDB-06972985351221 EUDAMEDB-06972985352150 EUDAMEDB-06972985351153 EUDAMEDB-06972985352167 EUDAMEDB-06972985352204 EUDAMEDB-06972985351238 EUDAMEDB-06972985351108 EUDAMEDB-06972985352228 EUDAMEDB-06972985352280 EUDAMEDB-06972985352181 EUDAMEDB-06972985352235 EUDAMEDB-06972985352211 EUDAMEDB-06972985352365 EUDAMEDB-06972985351214 EUDAMEDB-06972985351115 EUDAMEDB-06972985352334 EUDAMEDB-06972985351269 EUDAMEDB-06972985351139 EUDAMEDB-06972985352303 EUDAMEDB-06972985352112 EUDAMEDB-06972985351160 EUDAMEDB-06972985352266 EUDAMEDB-06972985352273 EUDAMEDB-06972985352105 EUDAMED
- EMDN Code
- C04030102 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC 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
Disposable Guide Wire by Ortus Medi-Tech Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06972985351283 | 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 (25)
- EUDAMED 0c85a889-8a1d-4edd-8278-024807a74349 61 fields · synced Sep 17, 2026
- EUDAMED 1213d4b8-95c4-4a88-9b11-53fa43cfa458 61 fields · synced May 11, 2026
- EUDAMED 63891ed2-6dbc-4b47-9152-081bec61ae28 61 fields · synced May 16, 2026
- EUDAMED 916a2728-855b-498c-8b05-1ea0a6efe86d 61 fields · synced May 16, 2026
- EUDAMED 570dcf8b-ea21-47ca-8dc8-2a1862b2ae72 61 fields · synced May 16, 2026
- EUDAMED c60040f2-5c58-4609-abc5-0d3f5f32c608 61 fields · synced May 16, 2026
- EUDAMED 646ba2f0-3607-44bd-a414-0fe0b5d52097 61 fields · synced May 16, 2026
- EUDAMED a873cae4-4108-4cae-b0b6-7e5c774eccc5 61 fields · synced May 16, 2026
- EUDAMED 4ce07fa8-5ca1-4309-84b4-bdf044d6bdb9 61 fields · synced May 17, 2026
- EUDAMED 8a62e71b-6715-49cc-bdb4-d2fd4e2fc630 61 fields · synced May 17, 2026
- EUDAMED bd22b979-7850-47d8-9ca7-fe1f506a37bf 61 fields · synced May 17, 2026
- EUDAMED df90c9a2-4b29-4871-a703-0ca5d57f23df 61 fields · synced May 17, 2026
- EUDAMED d65d6e1b-97b2-4e9a-9e75-a98a902d04b8 61 fields · synced May 17, 2026
- EUDAMED d0648b57-d55b-4ed3-aa86-e44bd787546d 61 fields · synced May 17, 2026
- EUDAMED 610fee58-5517-49af-9bec-a69be83d8103 61 fields · synced May 17, 2026
- EUDAMED 4cf4821b-90ef-441a-a35e-d76e02f0180e 61 fields · synced May 18, 2026
- EUDAMED 681dd77f-42ec-4be1-a133-ae2ef47f3a0a 61 fields · synced May 18, 2026
- EUDAMED d0e85399-6173-4acc-bee6-73f6cb2442d7 61 fields · synced May 18, 2026
- EUDAMED fb1d826d-a8a0-4ed8-bb74-920c03ec7960 61 fields · synced May 18, 2026
- EUDAMED a850919f-8690-4e9f-ae40-6d739e8eccb0 61 fields · synced May 18, 2026
- EUDAMED 9f903ff6-fd66-40c6-939d-79c759599848 61 fields · synced May 18, 2026
- EUDAMED 9db4b341-44b9-4cf7-a1b8-424aac5278f1 61 fields · synced May 18, 2026
- EUDAMED b93f988b-60b1-4a15-a41d-79202b1f1f9b 61 fields · synced May 19, 2026
- EUDAMED 7a062901-640f-4408-b8c9-79db353300c4 61 fields · synced May 19, 2026
- EUDAMED 3300a3aa-b4bf-408b-a901-15a0e6554275 61 fields · synced May 19, 2026