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Barrier Envelopes
EUDAMEDClass I (EU MDR)
Ref #1Model #0，#1，#2，#3，#4，#0 with extended tab，#1 with extended tab，#2 with extended tab，#3with extended tab，#4 with extended tabRef #0 with extended tabRef #4Ref #2Ref DBE0601
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#1 EUDAMED#0 with extended tab EUDAMED#4 EUDAMED#2 EUDAMEDDBE0601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971241391445 EUDAMED06971241393005 EUDAMED06971241392992 EUDAMED06971241390639 EUDAMED06971241393470 EUDAMED06971241393609 EUDAMED06971241393616 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 (7)
- EUDAMED 415c3b73-4fc8-4196-89fb-7d6ca60ed455 61 fields · synced Oct 6, 2026
- EUDAMED 9a4c17a1-3511-4a1a-ae2f-a402221a26fc 61 fields · synced May 16, 2026
- EUDAMED df871ffa-2851-49a6-81ef-c4d039ecbc95 61 fields · synced May 17, 2026
- EUDAMED dc3e2dec-586c-4ac0-8577-d6d72f5b53d1 61 fields · synced May 17, 2026
- EUDAMED 63cd557f-fa8c-4c56-b05e-35419c5b98bb 61 fields · synced May 17, 2026
- EUDAMED 0d5eec42-5085-428e-ae14-288c6745fcfd 61 fields · synced May 17, 2026
- EUDAMED b2acf4d1-86d0-48a3-bdd9-a431a4718162 61 fields · synced May 18, 2026