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Guide Wire （Loach)
EUDAMEDClass IIa (EU MDR)
Ref 06936345102007Model 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-38260Ref 06936345102045Ref 06936345102052Ref 06936345105435Ref 06936345105398Ref 06936345101994Ref 06936345105473Ref 06936345101970Ref 06936345105411
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 EUDAMED06936345102007 EUDAMED06936345102045 EUDAMED06936345102052 EUDAMED06936345105435 EUDAMED06936345105398 EUDAMED06936345101994 EUDAMED06936345105473 EUDAMED06936345101970 EUDAMED06936345105411 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345102007 EUDAMED06936345102045 EUDAMED06936345102052 EUDAMED06936345105435 EUDAMED06936345105398 EUDAMED06936345101994 EUDAMED06936345105473 EUDAMED06936345101970 EUDAMED06936345105411 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 (9)
- EUDAMED 01b93273-7575-4ef0-aa79-e00da4060d79 61 fields · synced Oct 6, 2026
- EUDAMED 47762443-437d-4b83-b306-615a6b8cac9a 61 fields · synced May 17, 2026
- EUDAMED 7c0e7d85-5c1f-4eaa-acfd-91a02090390f 61 fields · synced May 17, 2026
- EUDAMED ff920c3f-9d3f-4384-898e-68537d8493b9 61 fields · synced May 18, 2026
- EUDAMED 9f94839f-a97d-4a6e-9f9e-4ce49a56ba40 61 fields · synced May 18, 2026
- EUDAMED 5f3ff5f0-ba70-44e8-ac44-e9e3784e9770 61 fields · synced May 18, 2026
- EUDAMED 6392f1b6-e1cb-4234-a04a-020c20e507f8 61 fields · synced May 18, 2026
- EUDAMED d2e1734d-9d5e-451f-a93c-9af3fea5b80f 61 fields · synced May 18, 2026
- EUDAMED 02c82bac-e1ad-448e-a774-76b5ad2860b3 61 fields · synced May 18, 2026