Identity
- Trade Name
- Yingtai FDA UDI
- Generic Name
- Blood donor bag tube divider/sealer FDA UDI
- Device Name
- tube sealer EUDAMEDTube sealer is an industrial device that uses heat and pressure to securely seal materials such as plastic films, non-woven fabrics, or composite materials. It is widely used in fields such as food packaging, pharmaceutical product sealing, industrial manufacturing, and laboratory research. With its efficient operation and reliable sealing, it is an ideal choice for ensuring product integrity and extending storage life. FDA UDI
- Model / Reference
- Iseal-100 EUDAMED055 EUDAMEDIseal-510 FDA UDI
- Description
- Tube sealer is an industrial device that uses heat and pressure to securely seal materials such as plastic films, non-woven fabrics, or composite materials. It is widely used in fields such as food packaging, pharmaceutical product sealing, industrial manufacturing, and laboratory research. With its efficient operation and reliable sealing, it is an ideal choice for ensuring product integrity and extending storage life. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976301910550 EUDAMEDFDA UDI
- Basic UDI-DI
- 697630191tubesealerBE EUDAMED
- Direct Marketing DI
- 06976301910550 EUDAMED
- FDA Product Code
- KSD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Blood donor bag tube divider/sealer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.9750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
tube sealer by Changsha Yingtai Instrument Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697630191tubesealerBE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Changsha Yingtai Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000034851
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 4cf1f9d2-ff5d-4dcb-88bf-1804ad6b9db1 61 fields · synced Jul 17, 2026
- FDA UDI f6112970-f015-4127-871a-2344d400a3d7 33 fields · synced May 30, 2026