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Single-use Balloon Dilatation Catheter
EUDAMEDClass IIa (EU MDR)
Ref WBC-22-180-OD55Ref WBC-22-240-OA55Ref TBQ-22-190-0420Ref TBQ-22-190-0440Ref WBC-22-180-OC55Ref WBC-22-180-OE55
Identity
- Trade Name
- Single-use Balloon Dilatation Catheter EUDAMED
- Device Name
- Single-use Balloon Dilatation Catheter EUDAMED
- Model / Reference
- WBC-22-180-OD55 EUDAMEDWBC-22-240-OA55 EUDAMEDTBQ-22-190-0420 EUDAMEDTBQ-22-190-0440 EUDAMEDWBC-22-180-OC55 EUDAMEDWBC-22-180-OE55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948318945344 EUDAMED06948318945436 EUDAMED06948318944873 EUDAMED06948318944880 EUDAMED06948318945337 EUDAMED06948318945351 EUDAMED
- Basic UDI-DI
- 694831892a005MD EUDAMED
- Direct Marketing DI
- 06948318945344 EUDAMED06948318945436 EUDAMED06948318944873 EUDAMED06948318944880 EUDAMED06948318945337 EUDAMED06948318945351 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 (11)
- EUDAMED 852e8a24-aed2-4bfb-abb7-fb6934214327 61 fields · synced Sep 17, 2026
- EUDAMED 67ce7aa4-b2ec-45a0-b405-275832edac42 61 fields · synced May 17, 2026
- EUDAMED 73e7070b-9763-4c85-a450-c643dbfbcae0 61 fields · synced May 18, 2026
- EUDAMED f90c509a-cb65-49e7-b43f-ee3db4259df4 61 fields · synced May 18, 2026
- EUDAMED 83278990-8896-4388-82d3-4880ad46c895 61 fields · synced May 18, 2026
- EUDAMED 84cc2d25-e37a-411c-a6e0-c73d41f8a79d 61 fields · synced May 19, 2026
- EUDAMED 2e810853-cd7f-4065-b13b-76976255cdaf 61 fields · synced Jun 20, 2026
- EUDAMED 2702305d-e50e-45cd-ba9f-23d5b9430a69 61 fields · synced Jul 9, 2026
- EUDAMED 7cfebe8b-d277-4745-817d-43fa6a76830d 61 fields · synced Jul 27, 2026
- EUDAMED bd472f13-3a6f-4e41-982c-8021740be579 61 fields · synced Aug 1, 2026
- EUDAMED db3dd3f3-6513-4fac-b0e3-3551099c2095 61 fields · synced Sep 17, 2026