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Barrier Envelopes
EUDAMEDClass I (EU MDR)
Ref #3Model #0，#1，#2，#3，#4，#0 with extended tab，#1 with extended tab，#2 with extended tab，#3with extended tab，#4 with extended tab
Identity
- Trade Name
- BARRIER ENVELOPES EUDAMED
- Device Name
- BARRIER ENVELOPES EUDAMED
- Model / Reference
- #0，#1，#2，#3，#4，#0 with extended tab，#1 with extended tab，#2 with extended tab，#3with extended tab，#4 with extended tab EUDAMED#3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971241392985 EUDAMED
- Basic UDI-DI
- 697124139DBE00015U EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Barrier Envelopes by Tangshan Zhengtong Exhibition Co., Ltd. — Class I — 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 | 697124139DBE00015U | Class I | Active |
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Manufacturer
- Manufacturer
- Tangshan Zhengtong Exhibition Co., Ltd.
- EUDAMED SRN
- CN-MF-000018452
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED b9bf3773-0b3c-4de9-bfad-6dc7b31a700f 61 fields · synced Jun 18, 2026