Identity
- Trade Name
- double one EUDAMED
- Device Name
- GLTSM001- Latex Probe Covers EUDAMED
- Model / Reference
- Type U, Type Y EUDAMEDType U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06901691000017 EUDAMED
- Basic UDI-DI
- 6901691GLTSM00187 EUDAMED
- EMDN Code
- T030101,T030102,T030103,T030199 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
Yes
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
double one by Guangzhou Double One Latex Products 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 | 6901691GLTSM00187 | Class I | Active |
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Manufacturer
- Manufacturer
- Guangzhou Double One Latex Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000023131
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 23337501-2835-4999-80dc-bc2992083487 61 fields · synced May 29, 2026