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Howell
EUDAMEDClass I (EU MDR)
Ref HE-608-SKModel HE-608-A,HE-608-K,HE-608-S,HE-608-SKF,HE-608-SK,HE-608-N,HE-608-NK,HE-608-P,HE-608-T,HE-608-MRef HE-608-SRef HE-K9Model HE-L500、HE-L600、HE-L700、HE-L700/500、HE-L500/500、HE-L600/600、HE-L700/700、HE-L5+3、HE-L5、HE-L3、HE-K9/4、HE-K4 、HE-K9、HE-L4、HE-K5Ref HE-07-3Model HE-04T-8, HE-05,HE-05-2, HE-04T-11, HE-04T-3, HE-04T-4, HE-04-A-2, HE-04T-1, HE-04-5, HE-04T-2, HE-T7-3-1, HE-04-11, HE-02-1-1-B, HE-02-1-1-A, HE-02-14, HE-05T-3, HE-07-8-1, HE-05T-6, HE-07-7-1, HE-02-T, HE-04T-9,HE-07-C,HE-05-5, HE-08-1,etc.Ref HE-07-4-2Ref HE-04-13-1Ref HE-04T-BRef HE-L500Ref HE-08-3Ref HE-L5Ref HE-05TRef HE-05T-4Ref HE-09-3Ref HE-508-CRef HE-L500/500Ref HE-07-ARef HE-K5Ref HE-K9/4Ref HE-09-2Ref HE-608-MRef HE-07-BRef HE-04-4Ref HE-07-8-1Ref HE-04-5Ref HE-508-ARef HE-02-1-2-ARef HE-608-TRef HE-02-1-CRef HE-608-SKFRef HE-508-DRef HE-L700Ref HE-L4Ref HE-04-3Ref HE-L600/600Ref HE-608-ARef HE-02-2Ref HE-L600Ref HE-608-P
by Harbin Howell Medical Apparatus and Instruments Co., Ltd.
Identity
- Trade Name
- HOWELL EUDAMED
- Device Name
- Surgical Operating Table EUDAMEDShadowless Operating Lamp EUDAMEDPolymer Gel Pads EUDAMED
- Model / Reference
- HE-608-A,HE-608-K,HE-608-S,HE-608-SKF,HE-608-SK,HE-608-N,HE-608-NK,HE-608-P,HE-608-T,HE-608-M EUDAMEDHE-608-SK EUDAMEDHE-608-S EUDAMEDHE-L500、HE-L600、HE-L700、HE-L700/500、HE-L500/500、HE-L600/600、HE-L700/700、HE-L5+3、HE-L5、HE-L3、HE-K9/4、HE-K4 、HE-K9、HE-L4、HE-K5 EUDAMEDHE-K9 EUDAMEDHE-04T-8, HE-05,HE-05-2, HE-04T-11, HE-04T-3, HE-04T-4, HE-04-A-2, HE-04T-1, HE-04-5, HE-04T-2, HE-T7-3-1, HE-04-11, HE-02-1-1-B, HE-02-1-1-A, HE-02-14, HE-05T-3, HE-07-8-1, HE-05T-6, HE-07-7-1, HE-02-T, HE-04T-9,HE-07-C,HE-05-5, HE-08-1,etc. EUDAMEDHE-07-3 EUDAMEDHE-07-4-2 EUDAMEDHE-04-13-1 EUDAMEDHE-04T-B EUDAMEDHE-L500 EUDAMEDHE-08-3 EUDAMEDHE-L5 EUDAMEDHE-05T EUDAMEDHE-05T-4 EUDAMEDHE-09-3 EUDAMEDHE-508-C EUDAMEDHE-L500/500 EUDAMEDHE-07-A EUDAMEDHE-K5 EUDAMEDHE-K9/4 EUDAMEDHE-09-2 EUDAMEDHE-608-M EUDAMEDHE-07-B EUDAMEDHE-04-4 EUDAMEDHE-07-8-1 EUDAMEDHE-04-5 EUDAMEDHE-508-A EUDAMEDHE-02-1-2-A EUDAMEDHE-608-T EUDAMEDHE-02-1-C EUDAMEDHE-608-SKF EUDAMEDHE-508-D EUDAMEDHE-L700 EUDAMEDHE-L4 EUDAMEDHE-04-3 EUDAMEDHE-L600/600 EUDAMEDHE-608-A EUDAMEDHE-02-2 EUDAMEDHE-L600 EUDAMEDHE-608-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974445420041 EUDAMED06974445420027 EUDAMED06974445421123 EUDAMED06974445422649 EUDAMED06974445422861 EUDAMED06974445422588 EUDAMED06974445422007 EUDAMED06974445421000 EUDAMED06974445422250 EUDAMED06974445421086 EUDAMED06974445422960 EUDAMED06974445423134 EUDAMED06974445423042 EUDAMED06974445420126 EUDAMED06974445421048 EUDAMED06974445422656 EUDAMED06974445421147 EUDAMED06974445421109 EUDAMED06974445422731 EUDAMED06974445420096 EUDAMED06974445422595 EUDAMED06974445423295 EUDAMED06974445422168 EUDAMED06974445422083 EUDAMED06974445420102 EUDAMED06974445423257 EUDAMED06974445420089 EUDAMED06974445422373 EUDAMED06974445420034 EUDAMED06974445420133 EUDAMED06974445421024 EUDAMED06974445421130 EUDAMED06974445422953 EUDAMED06974445421055 EUDAMED06974445420003 EUDAMED06974445422489 EUDAMED06974445421017 EUDAMED06974445420072 EUDAMED
- Basic UDI-DI
- 697444542HE608EC EUDAMED697444542HE700/500JK EUDAMED697444542HETWD02-2P4 EUDAMED
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMEDZ12010701 FIXED SCIALYTIC LAMPS EUDAMEDV080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMEDV080302,Z12011202 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDGreece EUDAMEDAustria 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
Howell by Harbin Howell Medical Apparatus and Instruments Co., Ltd. — 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 | 697444542HE608EC | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000025141
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (38)
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