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Disposable Angiography Syringes without needle
EUDAMEDClass I (EU MDR)
Ref OM-AS01-2004Ref OM-AS02-1201Ref AS01Model AS01-0301Ref OM-AS01-0605Ref OM-AS01-0601Ref OM-AS01-2005Ref OM-AS01-1002Ref OM-AS01-1003Ref OM-AS01-0603Ref OM-AS01-0302Ref OM-AS01-2002Ref OM-AS01-1004Ref OM-AS02-1001
Identity
- Trade Name
- Disposable Angiography Syringes without needle EUDAMED
- Device Name
- Disposable Angiography Syringes without needle EUDAMED
- Model / Reference
- OM-AS01-2004 EUDAMEDOM-AS02-1201 EUDAMEDAS01-0301 EUDAMEDAS01 EUDAMEDOM-AS01-0605 EUDAMEDOM-AS01-0601 EUDAMEDOM-AS01-2005 EUDAMEDOM-AS01-1002 EUDAMEDOM-AS01-1003 EUDAMEDOM-AS01-0603 EUDAMEDOM-AS01-0302 EUDAMEDOM-AS01-2002 EUDAMEDOM-AS01-1004 EUDAMEDOM-AS02-1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985350194 EUDAMED06972985350217 EUDAMED06972985350019 EUDAMED06972985350101 EUDAMED06972985350064 EUDAMED06972985350200 EUDAMED06972985350125 EUDAMED06972985350132 EUDAMED06972985350088 EUDAMED06972985350026 EUDAMED06972985350170 EUDAMED06972985350149 EUDAMED06972985350224 EUDAMED
- Basic UDI-DI
- B-06972985350194 EUDAMEDB-06972985350217 EUDAMEDB-06972985350019 EUDAMEDB-06972985350101 EUDAMEDB-06972985350064 EUDAMEDB-06972985350200 EUDAMEDB-06972985350125 EUDAMEDB-06972985350132 EUDAMEDB-06972985350088 EUDAMEDB-06972985350026 EUDAMEDB-06972985350170 EUDAMEDB-06972985350149 EUDAMEDB-06972985350224 EUDAMED
- EMDN Code
- A020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMEDA020102010102 INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDTürkiye 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Angiography Syringes without needle by Ortus Medi-Tech Co., Ltd — Class I — 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-06972985350194 | Class I | 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 (13)
- EUDAMED 1bf7e73c-2cd1-4ad0-9c9e-2a54c943de74 61 fields · synced Aug 2, 2026
- EUDAMED ccc4e3c8-5378-4566-b71d-8ae0e03f5149 61 fields · synced May 16, 2026
- EUDAMED 3bafcb78-b6ff-4d5f-a4b6-a487e85e2236 61 fields · synced May 17, 2026
- EUDAMED 98985786-18b0-4d19-9940-cc7fd4c75926 61 fields · synced May 17, 2026
- EUDAMED 60919d80-530a-46a4-8b53-58ef8b2a54f3 61 fields · synced May 17, 2026
- EUDAMED 85a660ca-a12f-41f3-bc59-c6a96dad485b 61 fields · synced May 18, 2026
- EUDAMED 6e6cad82-9a48-44ee-9d4f-5f8ca13868ae 61 fields · synced May 18, 2026
- EUDAMED e0f844a9-678d-4eb5-883d-cf4bca1c6f8f 61 fields · synced May 18, 2026
- EUDAMED 14b29e69-b52e-47af-8c7c-1e21a5a2f8c0 61 fields · synced May 18, 2026
- EUDAMED 92fd8567-4c2c-40b9-a4e0-b39e36af86c8 61 fields · synced May 18, 2026
- EUDAMED e0986321-79c1-4f37-8529-5dd836231285 61 fields · synced May 18, 2026
- EUDAMED 0816303c-e829-4b19-b68b-f34a3f7d2621 61 fields · synced May 19, 2026
- EUDAMED 9f894d8d-42ba-47a6-9b7a-67f5e6a2c4e4 61 fields · synced May 19, 2026