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Gastric Calibration Tube
EUDAMEDClass IIa (EU MDR)
Ref GCT90034CModel with cuff
Identity
- Trade Name
- Gastric Calibration Tube EUDAMED
- Device Name
- Gastric Calibration Tube EUDAMED
- Model / Reference
- with cuff EUDAMEDGCT90034C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310908641 EUDAMED
- Basic UDI-DI
- 69233109GCTCPE EUDAMED
- EMDN Code
- G020502 GASTRIC CALIBRATION TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Gastric Calibration Tube by Hangzhou Formed Medical Devices 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 | 69233109GCTCPE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 62ed0bee-9376-46ed-81fc-7fb5697203a8 61 fields · synced Jun 18, 2026