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Sunmed™ disposable balloon inflation devices
EUDAMEDFDA UDIClass I (EU MDR)
Ref SM-ID-S3040H-TB
Identity
- Trade Name
- Sunmed™ disposable balloon inflation devices EUDAMEDSunmed Inflation devices FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- Disposable balloon inflation devices EUDAMED
- Model / Reference
- SM-ID-S3040H-TB EUDAMEDS-type, 30ml, 40atm/bar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947358563402 EUDAMEDFDA UDI
- Basic UDI-DI
- 694735850006LF EUDAMED
- 510(k) Number
- K133795 FDA UDI
- FDA Product Code
- MAV FDA UDI
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Sunmed™ disposable balloon inflation devices 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 | 694735850006LF | 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 cd5aaaf6-ee4c-49ea-b76a-67f0f67edd70 61 fields · synced Jul 13, 2026
- FDA UDI 20f7d66b-081b-489c-b235-7ea82c7a4c58 33 fields · synced May 30, 2026