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Sunmed™ disposable inflation device kits
EUDAMEDClass IIa (EU MDR)
Ref SM-ID-A2530HP13-TBRef SM-ID-F3030HC14-TBRef SM-ID-F3030HC26-TBRef SM-ID-F3030HPS21-TBRef SM-ID-S3030HS17-TBRef SM-ID-A2530HP26-TBRef SM-ID-A2530HC14-TBRef SM-ID-S3030HC17-TB
Identity
- Trade Name
- Sunmed™ disposable inflation device kits EUDAMED
- Device Name
- Disposable inflation device kits EUDAMED
- Model / Reference
- SM-ID-A2530HP13-TB EUDAMEDSM-ID-F3030HC14-TB EUDAMEDSM-ID-F3030HC26-TB EUDAMEDSM-ID-F3030HPS21-TB EUDAMEDSM-ID-S3030HS17-TB EUDAMEDSM-ID-A2530HP26-TB EUDAMEDSM-ID-A2530HC14-TB EUDAMEDSM-ID-S3030HC17-TB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947358562610 EUDAMED06947358565345 EUDAMED06947358565154 EUDAMED06947358565536 EUDAMED06947358563228 EUDAMED06947358562153 EUDAMED06947358562306 EUDAMED06947358563020 EUDAMED
- Basic UDI-DI
- 694735850008LK EUDAMED
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDSpain EUDAMEDBulgaria EUDAMEDItaly 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 (8)
- EUDAMED d453c647-2d6a-4e7a-9caf-8e595f1315d6 61 fields · synced Aug 4, 2026
- EUDAMED 69e8c970-26e3-4bf4-ab8e-ae447b691254 61 fields · synced May 18, 2026
- EUDAMED fe87ce0a-7328-4468-bf75-6a3ef83fa10e 61 fields · synced May 18, 2026
- EUDAMED 59228146-7ecb-4a9e-bd99-4ad4984d9450 61 fields · synced May 18, 2026
- EUDAMED 69e40e68-e2c8-4e6d-90b0-161fb2aab79e 61 fields · synced May 18, 2026
- EUDAMED 71e07903-b009-40c8-86c0-9458a3aedeee 61 fields · synced May 18, 2026
- EUDAMED 5c4b4586-68bf-4888-824b-09031deeddfe 61 fields · synced May 19, 2026
- EUDAMED 40ab47ae-681f-4cfb-b038-b8dc94a06d04 61 fields · synced May 19, 2026