← Back to catalogue
isolation gown
EUDAMEDClass I (EU MDR)
Ref OH-3000Model OH-3000, OH-4000, OH-4001, OH-5000, OH-5003R, OH-7001, OH-7002, OH-0010, OH-0011, OH-0012, OH-0013
Identity
- Device Name
- isolation gown EUDAMED
- Model / Reference
- OH-3000, OH-4000, OH-4001, OH-5000, OH-5003R, OH-7001, OH-7002, OH-0010, OH-0011, OH-0012, OH-0013 EUDAMEDOH-3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976803780019 EUDAMED
- Basic UDI-DI
- 697680378IG01P4 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
isolation gown by Wuhan Orient Honest International Trade 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 | 697680378IG01P4 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Orient Honest International Trade Co., Ltd
- EUDAMED SRN
- CN-MF-000037844
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b0d82dd8-95ac-4782-a2c7-a92d3c707de3 61 fields · synced Jun 18, 2026