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Single-use Balloon Dilatation Catheter
EUDAMEDClass IIa (EU MDR)
Ref WBC-22-180-OA55
Identity
- Trade Name
- Single-use Balloon Dilatation Catheter EUDAMED
- Device Name
- Single-use Balloon Dilatation Catheter EUDAMED
- Model / Reference
- WBC-22-180-OA55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948318945313 EUDAMED
- Basic UDI-DI
- 694831892a005MD EUDAMED
- Direct Marketing DI
- 06948318945313 EUDAMED
- EMDN Code
- G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDBulgaria 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
Single-use Balloon Dilatation Catheter by Anrei Medical (HZ) 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 | 694831892a005MD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Anrei Medical (HZ) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009964
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 1c40f9fb-21ec-4b82-8e0d-0552299b2f1b 61 fields · synced Jun 19, 2026
- EUDAMED 716c67be-9c2a-4d16-84c2-976c15131b67 61 fields · synced Jun 19, 2026