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Guide Wire （Loach)
EUDAMEDClass IIa (EU MDR)
Ref 06936345102021Model ZSR-GHS-28150 ZSR-GHS-32150B ZSR-GHS-32260 ZSR-GHS-35150 ZSR-GHS-35260 ZSR-GHS-38150 ZSR-GHS-38260 ZSR-GHJ-28150 ZSR-GHJ-32150 ZSR-GHJ-32260 ZSR-GHJ-35150 ZSR-GHJ-35260 ZSR-GHJ-38150 ZSR-GHJ-38260
Identity
- Trade Name
- Guide Wire （Loach) EUDAMED
- Device Name
- Guide Wire （Loach) EUDAMED
- Model / Reference
- ZSR-GHS-28150 ZSR-GHS-32150B ZSR-GHS-32260 ZSR-GHS-35150 ZSR-GHS-35260 ZSR-GHS-38150 ZSR-GHS-38260 ZSR-GHJ-28150 ZSR-GHJ-32150 ZSR-GHJ-32260 ZSR-GHJ-35150 ZSR-GHJ-35260 ZSR-GHJ-38150 ZSR-GHJ-38260 EUDAMED06936345102021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345102021 EUDAMED
- Basic UDI-DI
- 69363451ZSRGWL009A2 EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Guide Wire （Loach) by Dongguan ZSR Biomedical Technology Company Limited — 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 | 69363451ZSRGWL009A2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan ZSR Biomedical Technology Company Limited
- EUDAMED SRN
- CN-MF-000016828
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 9032628c-6bff-4640-81a9-a765c2178fc6 61 fields · synced Jun 20, 2026