← Back to catalogue
SIMPLE Post-Op Knee Brace K2, Cool wrap soft goods
EUDAMEDClass I (EU MDR)
Ref 11017-LModel 11003&11004&11012&11013&11016&11018&11019&11022&11049&11050(S/M/L/XL),11007&11011&11014&11059,11005&11006(S/M/L/XL/XXL),11017 (S/L)),
Identity
- Trade Name
- SIMPLE Post-Op Knee Brace K2,Cool wrap soft goods EUDAMED
- Device Name
- SIMPLE Dual Upright Knee Brace H1，SIMPLE OA Knee Brace X1，SIMPLE Premium OA Knee Brace S2，SIMPLE Dual Upright Knee Brace H2，SIMPLE Premium Post-Op Knee Brace K1，SIMPLE Knee Immobilizer K3，SIMPLE Post-Op Knee Brace K2，， EUDAMED
- Model / Reference
- 11003&11004&11012&11013&11016&11018&11019&11022&11049&11050(S/M/L/XL),11007&11011&11014&11059,11005&11006(S/M/L/XL/XXL),11017 (S/L)), EUDAMED11017-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244544282 EUDAMED
- Basic UDI-DI
- 697124454KneeOrthosesED EUDAMED
- Direct Marketing DI
- 06971244544282 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
SIMPLE Post-Op Knee Brace K2, Cool wrap soft goods by Simple Medical (Shenzhen) Limited — 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 | 697124454KneeOrthosesED | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Simple Medical (Shenzhen) Limited
- EUDAMED SRN
- CN-MF-000013198
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED dd317bef-4113-4101-aae7-0c6bfecb44fd 61 fields · synced Jul 9, 2026