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Sunmed™ balloon inflation devices
EUDAMEDClass I (EU MDR)
Ref SM-ID-S3030HS50-TB
Identity
- Trade Name
- Sunmed™ balloon inflation devices EUDAMED
- Device Name
- Disposable balloon inflation devices EUDAMED
- Model / Reference
- SM-ID-S3030HS50-TB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947358563242 EUDAMED
- Basic UDI-DI
- 694735850006LF EUDAMED
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Sunmed™ balloon inflation devices by Sunny Medical Device (Shenzhen) Co.Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694735850006LF | Class I | Active |
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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 (1)
- EUDAMED c8a56d16-cd77-414c-845f-7350383ee64e 61 fields · synced Jul 20, 2026