Identity
- Trade Name
- Specimen bag EUDAMED
- Device Name
- SPECIMEN BAG EUDAMED
- Model / Reference
- SB0609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977995690025 EUDAMED
- Basic UDI-DI
- 697799569LABSZB001HH EUDAMED
- EMDN Code
- W05020105 SAMPLES TRANSPORT, BAGS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Specimen bag by Heng Rong (xiamen) Plastic Products Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697799569LABSZB001HH | Class A | Active |
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Manufacturer
- Manufacturer
- Heng Rong (xiamen) Plastic Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000043934
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 304e22b7-f160-4c25-83b7-d89d52d5fceb 61 fields · synced Jun 19, 2026