Identity
- Device Name
- Interfacing apron(Isolation gown) EUDAMED
- Model / Reference
- PM12016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970879337443 EUDAMED
- Basic UDI-DI
- 697087933PM12016P9 EUDAMED
- EMDN Code
- T0209 SURGICAL APRONS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Interfacing apron(Isolation gown) by Ningbo Pinmed Instruments 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 | 697087933PM12016P9 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Pinmed Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000008488
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8dac80a8-e65f-4153-8649-8fc7e3323bf9 61 fields · synced Jun 20, 2026