Identity
- Trade Name
- Inflation Device EUDAMEDAntmed FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, perfusing FDA UDI
- Device Name
- Inflation Device EUDAMED
- Model / Reference
- ID1221 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945764406627 EUDAMED06945764414011 FDA UDI
- Basic UDI-DI
- 69457644ID00000006MS EUDAMED
- 510(k) Number
- K102648 FDA UDI
- FDA Product Code
- MAV FDA UDI
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
- GMDN Term
- Coronary angioplasty balloon catheter, perfusing FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Inflation Device by ShenZhen Antmed Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69457644ID00000006MS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Antmed Co., Ltd
- EUDAMED SRN
- CN-MF-000029659
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (2)
- EUDAMED ac5384c3-af2e-4303-bebd-b514e88a0dd2 61 fields · synced Jun 18, 2026
- FDA UDI ea41606f-c4e2-4d08-9e4d-50a4d4195bb9 34 fields · synced May 30, 2026