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Balloon Inflation Device
EUDAMEDFDA UDIClass I (EU MDR)
Ref 102001Model BID1, BID2, BID3Ref 104010Model BID2
Identity
- Trade Name
- Balloon inflation device FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- Balloon Inflation Device EUDAMED
- Model / Reference
- BID1, BID2, BID3 EUDAMED102001 EUDAMEDBID2 EUDAMED104010 EUDAMEDGT20ML FDA UDI
Identifiers
- Catalog Number
- 102001 FDA UDI
- Primary DI / UDI-DI
- 06936841227839 EUDAMED06936841239139 EUDAMED06971162817437 FDA UDI
- Basic UDI-DI
- 697116281BID10AJ EUDAMEDB-06936841239139 EUDAMED
- FDA Product Code
- PTM FDA UDI
- EMDN Code
- C0104010280 INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Balloon Inflation Device by Tianck Medical Co., Ltd. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697116281BID10AJ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697116281BID10AJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED a8fc8007-a2e9-4f23-9713-36777c962beb 61 fields · synced Oct 6, 2026
- FDA UDI ca9e8c74-1422-41db-a33c-aa219b4beb4c 33 fields · synced May 30, 2026
- EUDAMED 837a15eb-da93-47be-b61a-9150d1086247 61 fields · synced Jul 9, 2026