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ASAHI Gaia First Pre-shape
EUDAMEDClass III (EU MDR)
Ref AHW14R007PRef AHW14R007S
Identity
- Trade Name
- ASAHI Gaia First Pre-shape EUDAMEDASAHI Gaia First EUDAMED
- Device Name
- ASAHI PTCA Guide Wire ASAHI Gaia First, ASAHI Gaia Second, ASAHI Gaia Third EUDAMED
- Model / Reference
- AHW14R007P EUDAMEDAHW14R007S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327088084 EUDAMED04547327088107 EUDAMED
- Basic UDI-DI
- B-04547327088084 EUDAMEDB-04547327088107 EUDAMED
- EMDN Code
- C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria 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
ASAHI Gaia First Pre-shape by Asahi Intecc Co., Ltd. — Class III — 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-04547327088084 | Class III | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
- EUDAMED SRN
- JP-MF-000010199
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED cfcf3acb-46b6-40ba-b5d8-90a164a41a06 61 fields · synced Jul 28, 2026
- EUDAMED dd070251-a7cb-4a6b-8174-ad1b283785cb 61 fields · synced May 17, 2026