Identity
- Trade Name
- Shell Extraction Liner Standard EUDAMED
- Device Name
- Extractor EUDAMED
- Model / Reference
- 804-06-080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840277123015 EUDAMED
- Basic UDI-DI
- 8402771INNOEXTRACT0188 EUDAMED
- Direct Marketing DI
- 00840277123015 EUDAMED
- EMDN Code
- L0921 NON-IMPLANTABLE ORTHOPAEDIC DEVICES EXTRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Shell Extraction Liner Standard by Innomed, 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 | 8402771INNOEXTRACT0188 | Class I | Active |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED e753b39b-249b-47cb-87af-1db9e135dd67 61 fields · synced Jul 9, 2026