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SteriShape DC-PEM
EUDAMEDClass I (EU MDR)
Ref 560.123167.U2BModel OP-TapeRef 560.170220.R2ARef 560.133265.U2A
Identity
- Trade Name
- SteriShape DC-PEM EUDAMED
- Device Name
- OP-Tape EUDAMED
- Model / Reference
- OP-Tape EUDAMED560.123167.U2B EUDAMED560.170220.R2A EUDAMED560.133265.U2A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719925904769 EUDAMED08719925904813 EUDAMED08719925906572 EUDAMED
- Basic UDI-DI
- 871992590000TEQ EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
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
SteriShape DC-PEM by Eurotape B.V. — 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 | 871992590000TEQ | Class I | Active |
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Manufacturer
- Manufacturer
- Eurotape B.V.
- EUDAMED SRN
- NL-MF-000001956
Sources (3)
- EUDAMED f831b28d-c670-47a9-a132-37a03afa5d58 61 fields · synced Aug 2, 2026
- EUDAMED 9d8f39ae-e7a7-42ef-af57-012222c0b087 61 fields · synced May 17, 2026
- EUDAMED a93e9239-8cd1-4b89-811b-424e8f0d73c2 61 fields · synced May 19, 2026