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Sunmed™ disposable inflation device kits
EUDAMEDClass IIa (EU MDR)
Ref SM-ID-A2530HC26-TB
Identity
- Trade Name
- Sunmed™ disposable inflation device kits EUDAMED
- Device Name
- Disposable inflation device kits EUDAMED
- Model / Reference
- SM-ID-A2530HC26-TB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947358562351 EUDAMED
- Basic UDI-DI
- 694735850008LK EUDAMED
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sunmed™ disposable inflation device kits by Sunny Medical Device (Shenzhen) Co.Ltd — Class IIa — 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 | 694735850008LK | Class IIa | 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 efa5a8ec-73e4-4143-94ea-fe876b3fcb95 61 fields · synced Jul 4, 2026