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Sunmed™ pressure lines
EUDAMEDClass IIa (EU MDR)
Ref SM-PL-12P300RFP-TPRef SM-PL-12P120RF-MPRef SM-PL-05P030MF-MP
Identity
- Trade Name
- Sunmed™ pressure lines EUDAMED
- Device Name
- Pressure lines EUDAMED
- Model / Reference
- SM-PL-12P300RFP-TP EUDAMEDSM-PL-12P120RF-MP EUDAMEDSM-PL-05P030MF-MP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947358524311 EUDAMED06947358525332 EUDAMED06947358522539 EUDAMED
- Basic UDI-DI
- 694735850005LD EUDAMED
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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™ pressure lines 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 | 694735850005LD | 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 (3)
- EUDAMED 45b570c6-3567-4ab9-92c4-861b14e702a5 61 fields · synced Jul 21, 2026
- EUDAMED 0ba63d59-6fa4-4a7d-bf9c-40503ab97a5d 61 fields · synced May 17, 2026
- EUDAMED f829aceb-a169-4b97-8029-a625b492af78 61 fields · synced May 17, 2026