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Sunmed™ disposable angio-closure pads
EUDAMEDFDA UDIClass I (EU MDR)
Ref SM-AP-L-MP
Identity
- Trade Name
- Sunmed™ disposable angio-closure pads EUDAMEDSunmed disposable angio-closure pads FDA UDI
- Generic Name
- Femoral artery compression bandage, single-use FDA UDI
- Device Name
- Disposable angio-closure pads EUDAMED
- Model / Reference
- SM-AP-L-MP EUDAMEDLarge Size FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947358582618 EUDAMEDFDA UDI
- Basic UDI-DI
- 694735850011L8 EUDAMED
- FDA Product Code
- DXC FDA UDI
- EMDN Code
- C90010301 HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS) EUDAMED
- GMDN Term
- Femoral artery compression bandage, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Market of Registration
- Spain 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
No
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
Sunmed™ disposable angio-closure pads by Sunny Medical Device (Shenzhen) Co.Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 694735850011L8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunny Medical Device (Shenzhen) Co.Ltd
- EUDAMED SRN
- CN-MF-000022722
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED b26549d9-5aac-4d87-abf7-9d71ba166def 61 fields · synced Jul 25, 2026
- FDA UDI 30761c2e-a6bd-4150-b137-d40ce1fa8992 32 fields · synced May 30, 2026