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 EUDAMED050 EUDAMEDIseal-400 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
- 06976301910512 EUDAMEDFDA UDI
- Basic UDI-DI
- 697630191tubesealerBE EUDAMED
- Direct Marketing DI
- 06976301910512 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
tube sealer by Changsha Yingtai Instrument Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 b151eec5-f762-4546-947c-2717532c07df 61 fields · synced Jul 10, 2026
- FDA UDI 2bee08a8-c75b-47aa-b10d-99825e06adc6 33 fields · synced May 30, 2026