Identity
- Trade Name
- 13mm Bottles Vial Seals Next Gen EUDAMED
- Device Name
- Steri Tamp Vial Seals (Next Gen) EUDAMED
- Model / Reference
- ST2103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860010356555 EUDAMED
- Basic UDI-DI
- 08600103565VialSeals1CY EUDAMED
- EMDN Code
- A070599 CAPS OR OBTURATORS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
13mm Bottles Vial Seals Next Gen by CGR Minnesota LLC — 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 | 08600103565VialSeals1CY | Class I | Active |
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Manufacturer
- Manufacturer
- CGR Minnesota LLC
- EUDAMED SRN
- US-MF-000014503
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (1)
- EUDAMED 9e4b8d42-f3d2-4e95-9222-0ee7321a2ab9 61 fields · synced Jul 9, 2026