Identity
- Trade Name
- PWER-ENDO EUDAMED
- Device Name
- Disposable bougie dilators EUDAMED
- Model / Reference
- ENDO-BO EUDAMEDENDO-BO-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975597851134 EUDAMED
- Basic UDI-DI
- 697559785PE07UG EUDAMED
- EMDN Code
- G010101 OESOPHAGEAL BOUGIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Pwer-Endo by Jiangsu Power-endo Medical Technology 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 | 697559785PE07UG | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Power-endo Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000030213
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED c26bbe35-e7ad-4ebc-90ad-c17c1fbc1ee7 61 fields · synced Aug 4, 2026