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Single Use Guide Sheath Kit
EUDAMEDClass IIa (EU MDR)
Ref AF-D1610GS1Model Single Use Guide Sheath KitRef AF-D1912GS1
Identity
- Trade Name
- Single Use Guide Sheath Kit EUDAMED
- Device Name
- Single Use Guide Sheath Kit EUDAMED
- Model / Reference
- Single Use Guide Sheath Kit EUDAMEDAF-D1610GS1 EUDAMEDAF-D1912GS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127888564 EUDAMED06942127888601 EUDAMED
- Basic UDI-DI
- 697067138GK042DZ EUDAMED
- EMDN Code
- R070208 BRONCHOSCOPIC SURGERY KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Guide Sheath Kit by Alton (Shanghai) Medical Instruments 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 | 697067138GK042DZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alton (Shanghai) Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000012832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f19122d3-6726-43ea-af26-bc1ab29116b6 61 fields · synced Oct 6, 2026
- EUDAMED 6c1611d8-1726-46be-bb2e-88637ef1c755 61 fields · synced Jul 8, 2026