Identity
- Trade Name
- Enlarger™ EUDAMED
- Device Name
- Enlarger™ Inflation Device EUDAMED
- Model / Reference
- 191020S EUDAMED191020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949450411858 EUDAMED
- Basic UDI-DI
- 69494504IFD19R6 EUDAMED
- EMDN Code
- C01040180 CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Enlarger™ by APT Medical Inc. — 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 | 69494504IFD19R6 | Class I | Active |
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Manufacturer
- Manufacturer
- APT Medical Inc.
- EUDAMED SRN
- CN-MF-000009046
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 17341d43-e314-460e-b12d-d10dd0847cfd 61 fields · synced Jun 18, 2026