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Gastric Calibration Tube
EUDAMEDClass IIa (EU MDR)
Ref GCT90038SModel without cuffRef GCT105038Ref GCT90036Ref GCT90042CModel with cuffRef GCT90038CRef GCT90038BRef GCT90038VRef GCT90040CRef GCT90032CRef GCT90036CRef GCT105038BRef GCT90045BRef GCT90034B
Identity
- Trade Name
- Gastric Calibration Tube EUDAMED
- Device Name
- Gastric Calibration Tube EUDAMED
- Model / Reference
- without cuff EUDAMEDGCT90038S EUDAMEDGCT105038 EUDAMEDGCT90036 EUDAMEDwith cuff EUDAMEDGCT90042C EUDAMEDGCT90038C EUDAMEDGCT90038B EUDAMEDGCT90038V EUDAMEDGCT90040C EUDAMEDGCT90032C EUDAMEDGCT90036C EUDAMEDGCT105038B EUDAMEDGCT90045B EUDAMEDGCT90034B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310901925 EUDAMED06923310901949 EUDAMED06923310901864 EUDAMED06923310911276 EUDAMED06923310901918 EUDAMED06923310901895 EUDAMED06923310901901 EUDAMED06923310908665 EUDAMED06923310908696 EUDAMED06923310908658 EUDAMED06923310901956 EUDAMED06923310911252 EUDAMED06923310908627 EUDAMED
- Basic UDI-DI
- 69233109GCTXP EUDAMED69233109GCTCPE 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 | 69233109GCTXP | 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 (13)
- EUDAMED 14240162-7841-4a24-9bbd-287eaa537b8b 61 fields · synced Sep 18, 2026
- EUDAMED 16dce372-42cb-46aa-9181-a6e73882d46c 61 fields · synced May 11, 2026
- EUDAMED 4d4d53da-3b82-4649-b237-6c8a32887f45 61 fields · synced May 16, 2026
- EUDAMED c9ed83ee-419d-40c2-bd03-deab865f6a7e 61 fields · synced May 16, 2026
- EUDAMED 624490d7-5a80-4fe3-bcea-b7f3b03676d0 61 fields · synced May 16, 2026
- EUDAMED d8195dcf-fffd-4098-b1d6-889d02a87545 61 fields · synced May 17, 2026
- EUDAMED 39d02460-efb1-4ab0-9633-b2a7c6bcedbb 61 fields · synced May 17, 2026
- EUDAMED 810c4ef0-e967-4ca1-a494-58173fb3f767 61 fields · synced May 18, 2026
- EUDAMED d3b90528-2ba1-48d5-8561-bfbc4a0125ec 61 fields · synced May 18, 2026
- EUDAMED 86966e2f-9236-4478-8e6c-7d73125afa51 61 fields · synced May 18, 2026
- EUDAMED ab52e61b-e707-483c-becb-35fb2e40d616 61 fields · synced May 18, 2026
- EUDAMED 3a2b185e-71f3-4c8b-9247-d36369fe5ad1 61 fields · synced May 18, 2026
- EUDAMED 1f7a14d2-47b1-4c8f-ada8-09d4c66650aa 61 fields · synced May 19, 2026