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Disposable Blade
EUDAMEDClass I (EU MDR)
Ref ALC-H1BModel ALC-H1S,ALC-H1SL,ALC-H1M,ALC-H1ML,ALC-H1B,ALC-H1BL
Identity
- Trade Name
- Disposable Blade EUDAMED
- Device Name
- Disposable Blade EUDAMED
- Model / Reference
- ALC-H1S,ALC-H1SL,ALC-H1M,ALC-H1ML,ALC-H1B,ALC-H1BL EUDAMEDALC-H1B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970680131964 EUDAMED
- Basic UDI-DI
- 69706801332ALC4W EUDAMED
- Direct Marketing DI
- 06970680131964 EUDAMED
- EMDN Code
- R9002 LARYNGOSCOPE BLADES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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
Disposable Blade by Zhuhai Seesheen Medical Technology Co., Ltd. — Class I — CE/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 | 69706801332ALC4W | Class I | Active |
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Manufacturer
- Manufacturer
- Zhuhai Seesheen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027274
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 5e7b4a39-83bc-4c46-ad59-365d37f35b29 61 fields · synced Oct 7, 2026